On August 11, 2022 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 financial results and recent corporate highlights for the second quarter ended June 30, 2022 (Press release, Fortress Biotech, AUG 11, 2022, View Source [SID1234618214]).

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Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, "Fortress ended the first half of 2022 with $42.8 million in net revenue, which is a 45.5% increase over the same period last year. We currently have nine marketed prescription products and a growing portfolio of 20 clinical programs in over 30 ongoing clinical trials. We anticipate multiple important late-stage regulatory and clinical inflection points including the submission of a Biologics License Application ("BLA") to the U.S. Food and Drug Administration ("FDA") for cosibelimab for the treatment of metastatic cutaneous squamous cell carcinoma ("cSCC") and the continued rolling submission of Cyprium Therapeutics’s CUTX-101 New Drug Application ("NDA"). CUTX-101 is eligible for a priority review voucher upon FDA approval."

Dr. Rosenwald continued, "We believe that our business is well-positioned for growth in the coming months. Our business development team is targeting potentially exciting clinical stage medicines with proof-of-concept data in areas of unmet need. We remain focused on creating long-term shareholder value through asset monetizations, equity holdings/appreciation in our subsidiaries and partner companies, annual equity dividends and royalty revenues."

Recent Corporate Highlights1:

Marketed Dermatology Products and Product Candidates

Journey Medical Corporation ("Journey Medical"), a Fortress partner company, currently has nine prescription dermatology products.
Journey Medical generated net revenues of $18.3 million in the second quarter of 2022, compared to second quarter 2021 net revenues of $15.3 million, representing growth of 20%.
In March 2022, Journey Medical dosed the first patient in the Phase 3 clinical program of DFD-29 for the treatment of papulopustular rosacea. Topline data are anticipated in the first half of 2023 with an NDA filing expected in the second half of 2023.
In May 2022, Journey Medical announced that it entered into a settlement agreement with Padagis US LLC ("Padagis") pertaining to the patents protecting QBREXZA, the first and only prescription cloth towelette for the treatment of primary axillary hyperhidrosis, AMZEEQ, the first and only topical minocycline product for the treatment of acne, and ZILXI, the first and only topical minocycline product for the treatment of rosacea. Under terms of the paragraph IV settlement agreement, Padagis will not be allowed to launch generic versions of QBREXZA, AMZEEQ and ZILXI until August 15, 2030, July 1, 2031, and April 1, 2027, respectively.
Journey Medical intends to launch an additional prescription product in the second half of 2022.
CAEL-101 (Light Chain Fibril-reactive Monoclonal Antibody for AL Amyloidosis)

On October 5, 2021, AstraZeneca acquired Caelum Biosciences, Inc. ("Caelum") for an upfront payment of approximately $150 million paid to Caelum shareholders, of which approximately $56.9 million was paid to Fortress, net of Fortress’ $6.4 million portion of the $15 million, 24-month escrow holdback amount and other miscellaneous transaction expenses. The agreement also provides for additional potential payments to Caelum shareholders totaling up to $350 million, payable upon the achievement of regulatory and commercial milestones. Fortress is eligible to receive 42.4% of all potential milestone payments, which together with the upfront payment, would total up to approximately $212 million.
There are two ongoing Phase 3 studies of CAEL-101 for AL amyloidosis. (ClinicalTrials.gov identifiers: NCT04512235 and NCT04504825).
CAEL-101 was sourced by Fortress and was developed by Caelum until the acquisition by AstraZeneca in October 2021.
Cosibelimab (formerly CK-301, an anti-PD-L1 antibody)

In May 2022, we announced that Checkpoint Therapeutics, Inc. ("Checkpoint") received Pediatric Investigation Plan ("PIP") product-specific waivers from the European Medicines Agency ("EMA") and the U.K. Medicines & Healthcare products Regulatory Agency ("MHRA") for cosibelimab in cSCC. The waivers remove the requirement to conduct pediatric clinical studies to support cosibelimab marketing authorization applications in Europe.
In June 2022, we announced that the top-line results of our pivotal trial of cosibelimab in metastatic cSCC were presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Data highlights presented include confirmed objective response rate ("ORR") by independent central review in the modified intent-to-treat population of 48.7% (95% CI, 37.0-60.4) and 13.2% of patients achieved a complete response in target lesions. Cosibelimab was generally well tolerated with no unexpected safety signals. Checkpoint intends to submit a BLA to the FDA by the end of this year based on data from this pivotal cohort.
Also in June 2022, we announced positive interim results from our pivotal trial of cosibelimab in locally advanced cSCC. As of the March 2022 data cutoff, the confirmed ORR by independent central review in 31 patients was 54.8% (95% CI: 36.0, 72.7), substantially exceeding a clinically meaningful lower bound of the 95% two-sided confidence interval. Based on these positive results, Checkpoint intends to continue discussions with the FDA on the potential addition of locally advanced cSCC as a second indication in the planned BLA targeted for submission at year-end.
Cosibelimab was sourced by Fortress and is currently in development at our partner company, Checkpoint.
CUTX-101 (Copper Histidinate for Menkes disease)

In December 2021, we initiated the rolling submission of an NDA to the FDA for CUTX-101. The rolling submission of the NDA for CUTX-101 is ongoing.
Cyprium is currently in a dispute with its contract manufacturing organization ("the CMO"), regarding the CMO’s attempt to terminate a Master Services Agreement ("MSA") between Cyprium and the CMO. Additional details regarding the status of this dispute will be contained within the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2022.
CUTX-101 is currently in development at Cyprium Therapeutics, Inc.
MB-106 (CD20-targeted CAR T Cell Therapy)

In April 2022, we announced that interim Phase 1/2 data on MB-106, a CD20-targeted, autologous CAR T cell therapy for patients with relapsed or refractory B-cell non-Hodgkin lymphomas ("B-NHL") and chronic lymphocytic leukemia ("CLL"), were presented at the 2022 Tandem Meetings I Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy and Center for International Blood & Marrow Transplant Research. Data demonstrated high efficacy and a very favorable safety profile in all patients (n=25). Five dose levels were used during the study, and complete responses were observed at all dose levels. Durable responses were observed in a wide range of hematologic malignancies including follicular lymphoma ("FL"), CLL, diffuse large B-cell lymphoma ("DLBCL") and Waldenstrom macroglobulinemia ("WM"). An ORR of 96% and a complete response ("CR") rate of 72% were observed in all patients across all dose levels.
Also in April 2022, MB-106 data focused on CLL were presented at the 4th International Workshop on CAR-T and Immunotherapies.
In June 2022, we announced that MB-106 data were presented in an oral session at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress. Dr. Mazyar Shadman of Fred Hutch presented updated interim data from the ongoing Phase 1/2 clinical trial for B-NHL and CLL. Data presented include a 94% ORR and 78% CR rate in patients with FL. Overall, for the 26 patients treated on the trial, there was a 96% ORR and 73% CR, including complete responses in both DLBCL patients, both WM patients, and both patients previously treated with CD19-targeted CAR-T therapy (1 DLBCL patient and 1 FL patient).
Also in June 2022, we announced that the FDA granted Orphan Drug Designation to MB-106 for the treatment of WM, a rare type of B-NHL.
A Mustang Bio-sponsored multicenter Phase 1/2 clinical trial evaluating the safety and efficacy of MB-106 for relapsed or refractory B-NHL and CLL is enrolling patients, and dosing of the first patient is expected within the next 60 days.
MB-106 was sourced by Fortress and is currently in development at our partner company, Mustang Bio, Inc. ("Mustang Bio").
MB-107 and MB-207 (Lentiviral Gene Therapies for XSCID)

In May 2022, we announced that interim Phase 1/2 data on treatment with the same lentiviral vector used in MB-107, Mustang Bio’s lentiviral gene therapy for X-linked severe combined immunodeficiency ("XSCID"), also known as bubble boy disease, in newly diagnosed infants under the age of two, were presented in an oral presentation during the Clinical Trials Spotlight Symposium at the American Society of Gene & Cell Therapy 25th Annual Meeting. The presentation included updated data from a multicenter Phase 1/2 clinical trial for XSCID in newly diagnosed infants under the age of two at St. Jude Children’s Research Hospital, UCSF Benioff Children’s Hospital in San Francisco and Seattle Children’s Hospital. All 23 treated patients were alive at 2.6-year median follow-up without evidence of malignant transformation.
In 2023, we expect to enroll the first patient in a pivotal multicenter Phase 2 clinical trial under Mustang Bio’s Investigational New Product Drug Application ("IND") to evaluate MB-107, a lentiviral gene therapy for the treatment of infants under the age of two with XSCID.
Mustang Bio filed an IND application in December 2021 for its pivotal multicenter Phase 2 clinical trial of MB-207, a lentiviral gene therapy for the treatment of patients with XSCID who have been previously treated with a hematopoietic stem cell transplantation and for whom re-treatment is indicated. The trial is currently on hold pending CMC clearance from the FDA, and based on feedback from the FDA, Mustang Bio expects to enroll the first patient in a pivotal multicenter Phase 2 clinical trial in 2023.
MB-107 and MB-207 were sourced by Fortress and are currently in development at Mustang Bio.
Triplex (Cytomegalovirus ("CMV") Vaccine)

Earlier today we announced that Triplex received a grant from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health ("NIAID/NIH") that could provide over $20 million in non-dilutive funding. This competitive award will fund a multi-center, placebo-controlled, randomized Phase 2 study of Triplex for control of CMV in patients undergoing liver transplantation.
Triplex was sourced by Fortress and is currently in development at our subsidiary company, Helocyte.
Dotinurad (Urate Transporter (URAT1) Inhibitor)

In June 2022, we initiated a Phase 1 clinical trial to evaluate Dotinurad in healthy volunteers in the United States. Dotinurad is in development for the treatment of gout. We anticipate topline data from the Phase 1 trial in the second half of 2022. Dotinurad (URECE tablet) was approved in Japan in 2020 as a once-daily oral therapy for gout and hyperuricemia. Dotinurad was efficacious and well-tolerated in more than 500 Japanese patients treated for up to 58 weeks in Phase 3 clinical trials.
Dotinurad was sourced by Fortress and is currently in development at our subsidiary company, UR-1 Therapeutics.
MB-110 (Lentiviral Gene Therapy for RAG1 Severe Combined Immunodeficiency (RAG1-SCID))

In July 2022, we announced that the first patient successfully received LV-RAG1 ex vivo lentiviral gene therapy to treat recombinase-activating gene-1 ("RAG1") severe combined immunodeficiency ("RAG1-SCID"), in an ongoing Phase 1/2 multicenter clinical trial taking place in Europe. LV-RAG1 is exclusively licensed by Mustang Bio for the development of MB-110, a first-in-class ex vivo lentiviral gene therapy for the treatment of RAG1-SCID.
MB-110 was sourced by Fortress and is currently in development at Mustang Bio.
MB-109 (MB-101 IL13Rα2-targeted CAR T Cell Therapy + MB-108 C134 Oncolytic Virus)

In April 2022, we announced interim data from two ongoing investigator-sponsored Phase 1 clinical trials evaluating two clinical candidates, MB‐101 (IL13Rα2‐targeted CAR T cell therapy licensed from City of Hope) and MB-108 (herpes simplex virus type 1 oncolytic virus licensed from Nationwide Children’s Hospital) for the treatment of recurrent glioblastoma ("rGBM"). The data were from a late-breaking poster presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022. Preclinical data also presented support the safety of administering these two therapies sequentially to optimize treatment in a regimen designated as MB-109. Mustang expects to file an IND in 2023 to initiate an MB-109 Phase 1 clinical trial.
MB-101 and MB-108 were sourced by Fortress and they are currently in development at Mustang Bio.
General Corporate

In July 2022, we announced that David Jin, who has served as Head of Corporate Development since May 2020, was also appointed as Chief Financial Officer effective August 16, 2022.
Financial Results:

To assist our stockholders in understanding our company, we have prepared non-GAAP financial results for the three months ended June 30, 2022 and 2021. These results exclude the operations of our four public partner companies: Avenue Therapeutics, Inc. ("Avenue"), Checkpoint, Journey Medical and Mustang Bio, as well as any one-time, non-recurring, non-cash transactions. The goal in providing these non-GAAP financial metrics is to highlight the financial results of Fortress’ core operations, which are comprised of our privately held development-stage entities, as well as our business development and finance functions. See "Use of Non-GAAP Measures" below.

As of June 30, 2022, Fortress’ consolidated cash, cash equivalents and restricted cash totaled $251.0 million2, compared to $289.7 million as of March 31, 2022 and $308.0 million as of December 31, 2021, a decrease of $38.7 million during the prior quarter and a decrease of $57.0 million year-to-date.
On a GAAP basis, Fortress’ net revenue totaled $18.9 million for the second quarter of 2022, which included $18.2 million in net revenue generated from our marketed dermatology products. This compares to net revenue totaling $17.8 million for the second quarter of 2021, which included $15.3 million in net revenue generated from our marketed dermatology products.
On a GAAP basis, consolidated research and development expenses including license acquisitions were $33.1 million for the second quarter of 2022, compared to $33.8 million for the second quarter of 2021. On a non-GAAP basis, Fortress research and development expenses were $3.3 million for the second quarter of 2022, compared to $0.7 million for second quarter of 2021.
On a GAAP basis, consolidated selling, general and administrative expenses were $29.0 million for the second quarter of 2022, compared to $19.4 million for the second quarter of 2021. On a non-GAAP basis, Fortress selling, general and administrative expenses were $8.5 million, for the second quarter of 2022, compared to $7.1 million for the second quarter of 2021.
On a GAAP basis, consolidated net loss attributable to common stockholders was $21.4 million, or $0.24 per share, for the second quarter of 2022, compared to consolidated net loss attributable to common stockholders of $3.5 million, or $0.04 per share for the second quarter of 2021.
Fortress’ non-GAAP loss attributable to common stockholders was $8.9 million, or $0.10 per share, for the second quarter of 2022, compared to Fortress’ non-GAAP loss attributable to common stockholders of $6.4 million, or $0.08 per share, for the second quarter of 2021.
Use of Non-GAAP Measures:

In addition to the GAAP financial measures as presented in this press release and that will be presented in our Form 10-Q for the second quarter of 2022 to be filed with the Securities and Exchange Commission ("SEC"), the Company, in this press release, has included certain non-GAAP measurements. The non-GAAP net loss attributable to common stockholders is defined by the Company as GAAP net loss attributable to common stockholders, less net losses attributable to common stockholders from our public partner companies Avenue, Checkpoint, Journey Medical and Mustang Bio ("public partner companies"), as well as our former subsidiary, Caelum. In addition, the Company has also provided a Fortress non-GAAP loss attributable to common stockholders which is a modified EBITDA calculation that starts with the non-GAAP loss attributable to common stockholders and removes stock-based compensation expense, non-cash interest expense, amortization of licenses and debt discount, changes in fair values of investment, changes in fair value of derivative liability, and depreciation expense. The Company also provides non-GAAP research and development expenses including license acquisitions, defined as GAAP research and development costs, less research and development costs of our public partner companies and non-GAAP consolidated selling, general and administrative expenses, defined as GAAP selling, general and administrative expenses, less selling, general and administrative costs of our public partner companies.

Management believes each of these non-GAAP measures provide meaningful supplemental information regarding the Company’s performance because (i) it allows for greater transparency with respect to key measures used by management in its financial and operational decision-making; (ii) it excludes the impact of non-cash or, when specified, non-recurring items that are not directly attributable to the Company’s core operating performance and that may obscure trends in the Company’s core operating performance; and (iii) it is used by institutional investors and the analyst community to help analyze the Company’s standalone results separate from the results of its public partner companies. However, non-GAAP loss attributable to common stockholders and any other non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. Further, non-GAAP financial measures used by the Company and the manner in which they are calculated may differ from the non-GAAP financial measures or the calculations of the same non-GAAP financial measures used by other companies, including the Company’s competitors.

The tables below provide a reconciliation from GAAP to non-GAAP measures:

Results for the three and six months ended June 30, 2021 have been adjusted to present Journey Medical separately as a public entity.
Avenue net loss for the three months ended June 30, 2022 and 2021 of $0.6 million and $0.9 million, respectively, net of non-controlling interest of $0.3 million and $0.8 million, respectively. Avenue net loss for the six months ended June 30, 2022 and 2021 of $3.5 million and $1.9 million, respectively, net of non-controlling interest of $2.6 million and $1.5 million, respectively.
Checkpoint net loss of $14.1 million net of non-controlling interest of $11.4 million, Fortress management services agreement ("MSA") fee of $0.1 million for the three months ended June 30, 2022; and net loss of $9.1.0 million net of non-controlling interest of $7.1 million, Fortress MSA fee of $0.1 million, and Fortress financing fee of $0.3 million for the three months ended June 30, 2021; net loss of $31.0 million net of non-controlling interest of $25.0 million, Fortress MSA fee of $0.3 million, and Fortress financing fee of $0.2 million for the six months ended June 30, 2022; and net loss of $15.6 million net of non-controlling interest of $11.6 million, Fortress MSA fee of $0.3 million, and Fortress financing fee of $0.9 million for the three months ended June 30, 2021.
Journey Medical net loss for the three months ended June 30, 2022 of $7.5 million net of non-controlling interest of $2.8 million and tax benefit recognized on a stand-alone basis of $0.1 million; and net loss for the three months ended June 30, 2021 of $11.9 million, net non-controlling interest of approximately $1.2 million and tax benefit recognized on a stand-alone basis of $3.4 million; and net loss of $8.9 million net of non-controlling interest of $3.3 million and tax expense recognized on a stand-alone basis of $40,000 for the 6 months ended June 30, 2022, and net loss of $11.6 million net non-controlling interest of $1.2 million and tax benefit recognized on a stand-alone basis of $3.3 million for the six months ended June 30, 2021.
Mustang Bio net loss of $19.1 million net of non-controlling interest of $17.4 million, Fortress MSA fee of $0.3 million and Fortress financing fee of $0.1 million for the three months ended June 30, 2022; and net loss of $14.4 million net of non-controlling interest of $11.3 million, Fortress MSA fee of $0.1 million and Fortress financing fee of $0.4 million for the three months ended June 30, 2021; and net loss of $38.9 million net of non-controlling interest of $33.6 million, Fortress MSA fee of $0.5 million and Fortress financing fee of $0.9 million for the six months ended June 30, 2022; and net loss of $29.3 million net of non-controlling interest of $22.0 million, Fortress financing fee of $0.3 million and Fortress financing fee of $1.6 million for the six month period ended June 30, 2021.
Increase in fair value of investment in Caelum Biosciences for the quarter and six months ended June 30, 2021.
Reconciliation to non-GAAP research and development and general and administrative costs:

Results for the three and six months ended June 30, 2021 have been adjusted to present Journey Medical separately as a public entity.

Includes Research and development expense and Research and development – licenses acquired expense for the periods presented.

Excludes $0.1 million of Fortress MSA expense for the three months ended June 30, 2022 and 2021; $0.3 million of Fortress MSA expense for the six months ended June 30, 2022, and $0.1 million of Fortress MSA for the six months ended June 30, 2021.

Excludes $0.1 million of Fortress MSA expense for the three months ended June 30, 2022; and $0.1 million of Fortress MSA expense and $0.3 million Fortress financing fee for the three months ended June 30, 2021; and excludes $0.3 million Fortress MSA expense and $0.2 million Fortress financing fee for the six months ended June 30, 2022, and $0.3 million Fortress MSA expense and $0.9 million Fortress financing fee for the six months ended June 30, 2021.

Excludes $0.1 million of Fortress MSA expense and $0.1 million Fortress financing fee for the three months ended June 30, 2022; and $0.1 million of Fortress MSA expense and $0.4 million Fortress financing fee for the three months ended June 30, 2021; and excludes $0.3 million of Fortress MSA expense and $0.9 million Fortress financing fee for the six months ended June 30, 2022; and $0.1 million of Fortress MSA expense and $1.6 million Fortress financing fee for the six months ended June 30, 2021.

On August 11, 2022 Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC, OTC PINK:ENSCW), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety and performance focused on reducing abuse and overdose, reported financial results for the second quarter 2022 (Press release, Ensysce Biosciences, AUG 11, 2022, View Source [SID1234618213]).

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Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "With a recently completed $8 million financing, we are well positioned to advance our clinical trials. We also just announced that we achieved our stated milestone of positive bioequivalence (BE) study data from trial PF614-102 of our novel ‘TAAP’ opioid PF614. This study provides significant evidence of the progress we have made towards seeking to bring to market an important therapeutic option for pain management. Ultimately, the advances in our PF614 clinical development are the building blocks that enable our platforms to fully support our mission of developing a unique pipeline of safer pain products and helping millions who experience severe pain. To conclude, I want to thank all our constituents for their continued support."

TAAPTM (Opioid Abuse Deterrent Program) Updates

On July 27, 2022, the Company announced positive bioequivalence (BE) study data of its novel TAAP opioid PF614 from clinical trial PF614-102.
Study PF614-102 found that PF614 conformed to the FDA bioequivalence acceptance criteria when compared to OxyContin under both fasted and fed conditions.
The Company believes that the BE data from this study will support the 505(b)(2) regulatory path for clinical development of PF614, an abbreviated pathway to FDA approval. This pathway allows reference to available safety and clinical data from an approved product, and the BE data established by this study will move PF614 closer to registration. This positive BE data should allow the company to meet and communicate its Phase 3 plans with the FDA in 2023.
This PF614-102 study builds on the safety and pharmacokinetic results of the PF614 Phase 1 and 1b (Part A) studies and demonstrates the advantages we believe PF614 has over OxyContin, including a longer half-life, the limited food effect and the ability to deliver PF614 as an oral solution without losing its abuse deterrent properties for those who may have trouble swallowing.
This data is critical to understand future prescribing criteria for PF614 as an agent bioequivalent to OxyContin and the ability to substitute the use of PF614 for OxyContin.
PF614 is designed as an abuse-protected agent with trypsin-activated abuse protection (TAAP). TAAP chemical modification controls the release of the active ingredients in Ensysce’s opioid products including PF614, ‘turning on the release’ when exposed to trypsin. TAAP provides abuse protection and resistance to manipulation and other forms of recreational drug abuse.
MPARTM (Opioid Abuse Deterrent and Overdose Protection Program) Updates

On June 27, 2022, the Company announced its notice of award for the 4th year of funding for its Multi-Pill Abuse (MPAR) platform to support the final part of the ongoing clinical trial PF614-MPAR-101.
The amount awarded was $2.8 million and this brings total funding from NIDA under this grant to $10.8 million.
PF614-MPAR is a combination product with both trypsin-activated abuse protection (TAAP) and overdose protection through multi-pill abuse resistance (MPAR) technology. TAAP chemical modification controls the release of the active ingredient in PF614 providing abuse deterrence, and MPAR turns off the release in an overdose situation, providing the additional layer of protection.
Initial clinical data from PF614-MPAR-101 reported previously provided the first human data demonstrating the overdose protection of PF614-MPAR. The ongoing study will allow perfection of the drug product and aid in bringing this first overdose protected opioid to the market.
Financial Results

Cash – Cash and cash equivalents were $3.7 million as of June 30, 2022, as compared to $8.4 million as of March 31, 2022. Cash used in operating activities for the second quarter of 2022 totaled $4.4 million, an increase from $3.4 million in the first quarter of 2022 that primarily resulted from the clinical advancement of our product candidates. In July, we announced completion of a convertible notes financing for $8 million of gross proceeds received in the third quarter of 2022.
Federal Grants – Funding from federal grants was $0.2 million for the second quarter of 2022 compared to $0.4 in the comparable year ago quarter. Funding decreased by $0.2 million under the OUD Grant due to the timing of research activities eligible for funding. Funding under the MPAR grant in the second quarter was reduced because the annual funding limit through June 30, 2022, was reached. A fourth year of funding of the MPAR program was recently approved for $2.8 million covering the annual period through June 30, 2023.
Research & Development Expenses – R&D expenses were $5.3 million for the second quarter of 2022 compared to $0.5 million in the comparable year ago quarter. The increase was primarily the result of increased external research and development costs related to preclinical and clinical programs for PF614 and PF614-MPAR.
General & Administrative Expenses – G&A expenses were $2.0 million for the second quarter of 2022 compared to $0.4 million for the same period in 2021. The increase was primarily a result of increased expenses related to operating as a public company, including legal and accounting fees, fees incurred in connection with our recent financing, and director and officer insurance expenses.
Other Income (Expense) – Total other income (expense) was expense of $0.9 million in the second quarter of 2022 and expense of $0.5 million in the second quarter of 2021. The expense in the 2022 period is due to non-cash loss on debt conversions into common stock. The 2021 expense primarily reflects non-cash interest expense on notes that were converted on June 30, 2021.
Net Income (Loss) – Net loss for the second quarter of 2022 was $7.9 million compared to net loss of $1.0 million for the comparable year ago period. As a clinical stage biotech company, our continued research and development efforts toward regulatory approvals for our product candidates are expected to result in losses for the foreseeable future.
Additional Company Highlights

On July 1, 2022, the Company closed on $4.0 million of an $8.0 million convertible note financing, the remaining $4.0 million closed on August 9, 2022.
On July 13, 2022, the Company announced initial patients dosed in the first Human Abuse Potential study, PF614-103.
Corporate Update Conference Call

CEO, Dr. Lynn Kirkpatrick, CFO, Dave Humphrey, and CMO, Dr. Nily Osman will host a corporate update conference call on Wednesday, August 17, 2022, at 11:00am ET to provide a corporate update and review the recently discussed results and data from Clinical Trials PF614-102 and PF614-MPAR-101. The call will conclude with Q&A from participants. An accompanying presentation will be posted prior to the call to the Company’s investor relations website.

Please dial in at least 10 minutes before the start of the call to ensure timely participation. A playback of the call will be available through Wednesday, September 14, 2022. To listen, call 1-844-512-2921 within the United States and Canada or 1-412-317-6671 when calling internationally. Please use the replay pin number 13731880.

On August 11, 2022 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported financial results for the second quarter and six months ended June 30, 2022 and provided an update on recent business events (Press release, CorMedix, AUG 11, 2022, View Source [SID1234618212]).

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Recent Corporate Highlights:

CorMedix announced on August 8th that a second Complete Response Letter (CRL) was received from the FDA stating that the DefenCath NDA cannot be approved until deficiencies conveyed to the contract manufacturing organization (CMO) and the supplier of the active pharmaceutical ingredient (API) heparin during inspections are resolved to the satisfaction of FDA.
CorMedix has supported the efforts of the CMO to compile robust responses and corrective action plans to inspectional observations the CMO received during the FDA’s recent pre-approval inspection of the CMO for the DefenCath NDA. The CMO is engaging external consultants who are experienced in FDA’s requirements for CGMP compliance to accelerate the implementation of corrective actions.
The FDA conducted a recent inspection unrelated to DefenCath at the facility of the company’s heparin supplier, which culminated in the API supplier receiving a warning letter as a result of manufacturing deficiencies for a non-heparin API. The Company’s heparin supplier has advised CorMedix that it has retained an independent CGMP consultant to expedite the implementation of corrective actions and resolve the warning letter as quickly as possible.
CorMedix announced that it has entered into an agreement with Alcami Corporation, a US based contract manufacturer with proven capabilities for manufacturing commercial sterile parenteral drug products, which will serve as a manufacturing site for DefenCath. The Company has been working with Alcami over the past several months to transfer the manufacturing process for DefenCath into an Alcami site, and CorMedix expects to be able to submit a supplement to its NDA application around the end of the first quarter of 2023.
On August 1st, the Center for Medicare & Medicaid Services (CMS) published in the Federal Register the conditional New Technology Add on Payment (NTAP) reimbursement. The NTAP is conditioned upon the NDA obtaining final FDA approval prior to July 1, 2023, and would take effect in the first calendar quarter following such FDA approval of the NDA. The Company intends to submit a duplicate NTAP application in October of this year with the expectation of preserving eligibility for NTAP should final NDA approval occur after July 1, 2023.
Cash and short-term investments, excluding restricted cash, at June 30, 2022 amounted to $64.6 million.
Joe Todisco, CorMedix CEO, commented, "While I am disappointed that we will not receive FDA approval on our PDUFA date, I remain confident in our pathway forward to an FDA approval, once either our existing CMO and API supplier obtain compliance clearance, or we are able to obtain regulatory approval for manufacturing with Alcami. We have sufficient cash on hand to fund operations through at least the next four quarters, and the team is focused on obtaining FDA approval of the DefenCath NDA as quickly as possible. We look forward to providing additional updates as we aim to deliver on our commitment to these patients."

Second Quarter and Six Month 2022 Financial Highlights

For the second quarter 2022, CorMedix recorded a net loss of $7.6 million, or $0.19 per share, compared with a net loss of $4.6 million, or $0.12 per share, in the second quarter of 2021, an increase of $3.0 million or 65%. The higher net loss recognized in 2022 compared with 2021 included an increase in both SG&A expenses and R&D expenses versus the 2nd quarter of 2021. CorMedix recognized a tax benefit of $0.6 million in the second quarter of 2022 from the sale of our NJ Net Operating Losses compared with a $1.3 million benefit recorded in 2nd quarter of 2021.

Operating expenses in the second quarter of 2022 increased approximately 41% to $8.3 million, compared with $5.9 million in the second quarter of 2021. R&D expense increased approximately 28% to $3.2 million compared with $2.5 million in the second quarter of 2021, mainly due to an increase in costs related to the manufacturing of DefenCath prior to its potential marketing approval. SG&A expense increased approximately 50% to $5.1 million compared with $3.4 million in the second quarter of 2021. This increase was driven primarily by an increase in in costs related to market research studies and prelaunch activities in preparation for the potential marketing approval of DefenCath, and an increase in legal fees mainly due to the securities litigation.

For the six months ended June 30, 2022, CorMedix recorded a net loss of $14.6 million, or $0.38 per share, compared with a net loss of $11.8 million, or $0.32 per share, in the first half of 2021. Operating expenses in the first half of 2022 were $15.3 million, compared to $13.1 million in the first half of 2021, an increase of approximately 17%. This increase was primarily due to costs related to the manufacturing of DefenCath prior to its potential marketing approval, legal fees mainly due to the securities litigation, and personnel expenses.

The Company reported cash and short-term investments of $64.6 million at June 30, 2022, excluding restricted cash. The Company believes that it has sufficient resources to fund operations at least through the third quarter of 2023.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, August 11, 2022, at 8:30AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows:

On August 11, 2022 Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company focused on developing both restorative therapeutics for orthopedic indications and pan-caspase and caspase selective inhibitors focused on treatments for infectious and inflammatory diseases, reported financial results for the second quarter ended June 30, 2022 and provided an update on its clinical pipeline and other corporate developments (Press release, Conatus Pharmaceuticals, AUG 11, 2022, View Source [SID1234618211]).

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"We continue to focus on execution of IND enabling activities for HST 004 in spinal disc regeneration, exploration of testing emricasan in animal studies for methicillin resistant staphylococcus aureus infections ("MRSA") and evaluating our caspase-1 inhibitors that impact the inflammasome pathway," said Steven J. Mento, Ph.D., Interim President and Chief Executive Officer. "We also initiated a feasibility evaluation of our ongoing HST 003 study for cartilage regeneration in the knee, including implementation of protocol modifications, adding more sites, and other study resources given the continued recruitment challenges stemming from both the study protocol and impact of COVID-19 on the elective surgery environment and expect to complete our evaluation in the fourth quarter of 2022."

Highlights from the Second Quarter 2022 and Business Updates

HST 003 – Our Phase 1/2 clinical study of HST 003 to evaluate the safety and efficacy of human extracellular matrix (hECM) implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage in combination with a microfracture procedure is on-going. Despite adding three additional clinical sites in the first quarter of 2022, we continue to experience recruitment challenges due to both the specific nature of the study inclusion criteria and the impact of COVID-19 on the elective surgery environment. We are currently evaluating the overall feasibility of the ongoing HST 003 trial, including implementing protocol modifications, adding more sites, and other study resources. We expect to complete our feasibility evaluation in the fourth quarter of 2022.

HST 004 – Our initial preclinical research has shown that HST 004 stimulates stem cells from the spinal disc to proliferate and secrete aggrecan and collagen II, regenerates normal matrix and cell tissue structure and restores disc height. HST 004 was also shown to reduce inflammation and protease activity and upregulate aggrecan production in an ex vivo spinal disc model. We continue to execute on IND enabling activities for HST-004 and anticipate filing IND for HST-004 in the second half of 2023.
Emricasan MRSA – We continue to make progress on exploring the feasibility of testing emricasan in animal studies for MRSA. We expect to complete our feasibility assessment in the third quarter of 2022.

Regained Compliance with Nasdaq Minimum Bid Listing Requirement – On June 2, 2022, we effected a 1-for-20 reverse stock split of the Company’s issued and outstanding common stock, par value $0.0001 per share. Subsequently, we received written notice from the Listing Qualifications Department of the Nasdaq Stock Market stating that the Company has regained compliance with the Nasdaq minimum bid price listing requirement.

$5 Million Financing – In July 2022, we closed a $5 million private placement financing. We anticipate that the net proceeds, in addition to our cash of $12.6M as of June 30, 2022, will support our operations through December 2023.
Six Months Ended June 30, 2022 Financial Highlights

Product, License, and Grant Revenues

For the six months ended June 30, 2022 and 2021, we recognized product revenues of $0 and $0.3 million, respectively. The revenue for the first six months of 2021 was related to the additional supply of cell conditioned medium (CCM) to Allergan. As of March 31, 2021, all obligations of the Company related to the additional supply of CCM to Allergan under the Allergan Agreements have been completed.

For the six months ended June 30, 2022 and 2021, we recognized license revenue of $3.8 million and $17 thousand, respectively. The increase in the current period is due to a one-time payment of $3.8 million received in March 2022 as consideration for execution of the Allergan Letter Agreement.

For the six months ended June 30, 2022 and 2021, we recognized grant revenue of $0 and $0.1 million, respectively. The related revenue is associated with a research and development grant awarded to the Company from the National Science Foundation (NSF). As of March 31, 2021, all work required by the Company under the grant has been completed.

Cost of revenues for the six months ended June 30, 2022 and 2021, we recognized $0 and $0.2 million, respectively, for cost of product sold to Allergan under the Allergan Agreements.

Research and development expenses for the six months ended June 30, 2022 and 2021 were $3.0 million and $4.5 million, respectively. The decrease of $1.5 million was primarily due to decreases in development costs of our clinical and pre-clinical product candidates and personnel related expenses, partially offset by facility rent increases.

General and administrative expenses for the six months ended June 30, 2022 and 2021 were $4.8 million and $4.2 million, respectively. The increase of $0.6 million was primarily due to increases in royalty expenses and legal fees, offset by reductions in personnel related expenses.

Cash and cash equivalents as of June 30, 2022 were $12.6 million which excludes gross proceeds of approximately $5 million from the private placement financing closed in July 2022. Histogen believes that its existing cash and cash equivalents and cash inflow from operations will be sufficient to meet Histogen’s anticipated cash needs through December of 2023.

On August 11, 2022 Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a biotechnology company focused on pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, reported financial results for its second quarter 2022 and provided a corporate update (Press release, AmpliPhi Biosciences, AUG 11, 2022, View Source [SID1234618208]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Second Quarter 2022 and Recent Developments:

AP-PA02 advancing through final MAD cohort of SWARM-P.a. trial
Phase 2 Tailwind study of AP-PA02 in non‐CF bronchiectasis (NCFB) initiated
AP-SA02 Phase 1b/2a Staphylococcus aureus bacteremia study (‘diSArm’) actively enrolling
Pipeline expansion continues with IND approval for AP-SA02 in prosthetic joint infection
Engineered, second generation AP-PA02 therapeutic candidate selected
Continued investment in manufacturing capabilities
"During the second quarter, we continued to advance our portfolio of innovative bacteriophage therapeutics. We now have four approved INDs, positioning Armata to robustly evaluate bacteriophage effectiveness in difficult-to-treat infections," stated Dr. Brian Varnum, Chief Executive Officer of Armata. "At the same time, we continued to advance the science of bacteriophage. Armata’s synthetic biologists have engineered a second-generation AP-PA02 product with improved pharmacological properties. Additionally, significant improvements in manufacturing processes have resulted in improved yield and purity, with methods that are readily scalable. These methods lay the groundwork for the next phase of Armata’s growth as we build out our new 56,000 square foot facility."

Second Quarter 2022 Financial Results:

Grant Revenue. The Company recognized grant revenue of approximately $1.9 million for the three months ended June 30, 2022, which represents Medical Technology Enterprise Consortium’s ("MTEC") share of the costs incurred for the Company’s AP-SA02 program for the treatment of Staphylococcus aureus bacteremia. The Company expects to receive $15.0 million in grant funding from MTEC administered by the U.S. Department of Defense and the Defense Health Agency and Joint Warfighter Medical Research Program. The Company recognized approximately $1.2 million of revenue in the comparable period in 2021.

Research and Development. Research and development expenses for the three months ended June 30, 2022, were approximately $9.0 million as compared to approximately $5.2 million for the comparable period in 2021. The Company continues to invest in clinical trial and personnel related expenses associated with its primary development programs.

General and Administrative. General and administrative expenses for the three months ended June 30, 2022, were approximately $2.1 million as compared to approximately $2.1 million for the comparable period in 2021.

Loss from Operations. Loss from operations for the three months ended June 30, 2022, was $(9.2) million as compared to a loss from operations of approximately $(6.2) million for the comparable period in 2021.

Cash and Equivalents. As of June 30, 2022, Armata held approximately $37.0 million of unrestricted cash and cash equivalents, as compared to $10.3 million as of December 31, 2021.

As of August 9, 2022, there were approximately 36.1 million shares of the Company’s common stock outstanding.