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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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.

On August 11, 2022 Cullgen Inc., a leading biotechnology company developing targeted protein degraders based on its proprietary uSMITE platform technology, reported that the Chinese National Medical Products Administration (NMPA) has allowed the Investigational New Drug (IND) application for CG001419, a TRK degrader for the treatment of solid tumors (Press release, Cullgen, AUG 11, 2022, View Source [SID1234618176]). CG001419 is a first-in-class, selective, potent oral targeted protein degrader for the treatment of neurotrophic tyrosine receptor kinase (NTRK) fusion-positive cancers, which have been identified in numerous solid tumors including non-small cell lung, breast, and pancreatic cancers.

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Cullgen will commence a Phase I clinical trial program in humans for CG001419 in China promptly.

"NMPA’s allowance of this IND application for CG001419 represents an important milestone for Cullgen," said Dr. Yue Xiong, Cullgen’s co-founder and Chief Scientific Officer. "Our TRK degrader program was one of the first programs pursued by Cullgen, and this IND allowance by NMPA demonstrates that we are able to successfully advance a program from discovery phase into clinical development. In addition to cancer, we are also exploring other potential clinical indications of our TRK degraders."