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."

On August 11, 2022 AstraZeneca reported that it has completed the acquisition of TeneoTwo, Inc. (TeneoTwo)i, including its Phase I clinical-stage CD19/CD3 T-cell engager, TNB-486, currently under evaluation in relapsed and refractory B-cell non-Hodgkin lymphoma (Press release, AstraZeneca, AUG 11, 2022, View Source [SID1234618187]).1 AstraZeneca will develop TNB-486 as a potential new medicine for B-cell haematologic malignancies.

Financial considerations
AstraZeneca has acquired all outstanding equity of TeneoTwo in exchange for an upfront payment of $100m. Under the terms of the agreement, AstraZeneca will make additional contingent R&D-related milestone payments of up to $805m and additional contingent commercial-related milestone payments of up to $360m to TeneoTwo’s former equity holders.

This acquisition did not include the transfer of people or facilities.

iTeneoTwo, Inc., is a majority owned subsidiary company of TBio, LLC, a limited liability company formed in Delaware, US

Notes

AstraZeneca in haematology
AstraZeneca is pushing the boundaries of science to redefine care in haematology. We have expanded our commitment to patients with haematologic conditions, not only in oncology but also in rare diseases with the acquisition of Alexion, allowing us to reach more patients with high unmet needs. By applying our deep understanding of blood cancers, leveraging our strength in solid tumour oncology and delivering on Alexion’s pioneering legacy in complement science to provide transformative medicines for rare diseases, we are pursuing the end-to-end development of novel therapies designed to target underlying drivers of disease.

By targeting haematological conditions with high unmet medical needs, we aim to deliver innovative medicines and approaches to improve patient outcomes. Our goal is to help transform the lives of patients living with malignant, rare and other related haematologic diseases, shaped by insights from patients, caregivers and physicians to have the most meaningful impact.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

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On August 11, 2022 Verrica Pharmaceuticals Inc. (Verrica) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, reported financial results for the second quarter ended June 30, 2022 (Press release, Verrica Pharmaceuticals, AUG 11, 2022, View Source [SID1234618186]).

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"This quarter, we held a Type A meeting with the FDA regarding the path forward for the resubmission and potential approval of the New Drug Application (NDA) for VP-102 for the treatment of molluscum," said Ted White, Verrica’s President and Chief Executive Officer. "We also began working with an alternative supplier for the bulk solution of VP-102, Piramal Pharma Solutions, at their Sellersville, Pennsylvania site. Piramal’s experience in the commercial manufacturing of liquids combined with the facility’s close proximity to Verrica’s headquarters will allow our teams to work closely and collaboratively in the technology transfer process. Based on the feedback from the FDA and the timing of the technology transfer to Piramal, we expect to be able to resubmit the NDA for VP-102 for the treatment of molluscum contagiosum (molluscum) in the first quarter of 2023."

Business Highlights and Recent Developments

Corporate Highlights

Verrica executed an underwritten public offering of 13,575,000 shares of its common stock at a price to the public of $2.10 per share, which includes shares sold pursuant to the underwriter’s option to purchase additional shares. The gross proceeds from the offering to Verrica were approximately $28.5 million, before deducting underwriting discounts and commissions and offering expenses.
Verrica voluntarily repaid in full the debt outstanding under the mezzanine loan and security agreement using restricted cash of $40.0 million, which was set aside as cash collateral in a March 2022 amendment to the loan agreement, as well as cash on hand.
VP-102

Verrica announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding its NDA for VP-102 for the treatment of molluscum. According to the CRL, the only deficiency listed was related to the deficiencies identified at a general reinspection of the contract manufacturing organization (CMO) that manufactures Verrica’s bulk solution drug product. None of the issues identified by FDA during the reinspection were specific to the manufacturing of VP-102.
Verrica has begun working with Piramal Pharma Solutions to manufacture bulk solution for VP-102 at their Sellersville, Pennsylvania site. Verrica will continue to work closely with Piramal and the FDA to facilitate a timely technology transfer and production quality at the facility.
Verrica announced that it held a Type A Meeting with the FDA regarding the path forward for the resubmission and potential approval of the NDA for VP-102 for the treatment of molluscum. The FDA indicated a willingness to work collaboratively on the amount of stability data required from an alternative CMO for the bulk solution of VP-102 at the time of resubmission as well as options for post-approval use of bulk solution previously manufactured.
Financial Results

Second Quarter 2022 Financial Results

Verrica recognized license revenues of $0.2 million for the three months ended June 30, 2022 and no revenue for the same period in 2021 related to the Collaboration and License Agreement (the "Torii Agreement") with Torii Pharmaceutical Co., Ltd. ("Torii") for supplies and development activity with Torii.
Research and development expenses were $4.2 million in the second quarter of 2022, compared to $3.4 million for the same period in 2021. The increase was primarily attributable to a one-time $1.0 million milestone payment to Lytix Biopharma AS ("Lytix") upon the achievement of a regulatory milestone for LTX-315.
General and administrative expenses were $5.2 million in the second quarter of 2022, compared to $7.3 million for the same period in 2021. The decrease was primarily a result of higher expenses in the prior year related to pre-commercial activities for VP-102.
For the second quarter of 2022, net loss on a GAAP basis was $10.2 million, or $0.37 per share, compared to a net loss of $11.8 million, or $0.43 per share, for the same period in 2021.
For the second quarter of 2022, non-GAAP net loss was $8.8 million, or $0.32 per share, compared to a non-GAAP net loss of $9.6 million, or $0.35 per share, for the same period in 2021.
Year-to-Date June 2022 Financial Results

Verrica recognized license revenues related to the Torii Agreement of $0.6 million for the six months ended June 30, 2022 compared to $12.0 million for the same period in 2021. The license revenue for the six months ended June 30, 2022 related to Torii’s purchase of supplies and reimbursement for development activities while the 2021 license revenue was driven by the Torii upfront license milestone payment of $12.0 million.
Research and development expenses were $6.9 million for the six months ended June 30, 2022, compared to $8.8 million for the same period in 2021. The decrease was primarily attributable to one-time payments of $1.0 and $2.3 million to Lytix upon the achievement of regulatory milestones for LTX-315, during the six months ended June 30, 2022 and 2021, respectively, as well as decreased Chemistry, Manufacturing and Controls (CMC) and clinical costs related to Verrica’s development of VP-102 for molluscum contagiosum, external genital warts, and common warts in 2022.
General and administrative expenses were $10.3 million for the six months ended June 30, 2022, compared to $13.9 million for the same period in 2021. The decrease of $3.6 million was primarily a result of a decrease in expenses related to pre-commercial activities for VP-102.
For six months ended June 30, 2022, net loss on a GAAP basis was $18.6 million, or $0.68 per share, compared to a net loss of $12.7 million, or $0.46 per share, for the same period in 2021.
For the six months ended June 30, 2022, non-GAAP net loss was $15.6 million, or $0.57 per share, compared to a non-GAAP net loss of $8.8 million, or $0.32 per share, for the same period in 2021.
As of June 30, 2022, Verrica had aggregate cash, cash equivalents, marketable securities and restricted cash of $54.4 million. The Company believes that its existing cash, cash equivalents, and marketable securities as of June 30, 2022, together with the proceeds from the July 2022 underwritten public offering, will be sufficient to support planned operations into the third quarter of 2023.
Non-GAAP Financial Measures

In evaluating the operating performance of its business, Verrica’s management considers non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share. These non-GAAP financial measures exclude stock-based compensation charges and non-cash interest expense that are required by GAAP. Verrica believes that non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share provides useful information to both management and investors by excluding the effect of certain non-cash expenses and items that Verrica believes may not be indicative of its operating performance, because either they are unusual and Verrica does not expect them to recur in the ordinary course of its business, or they are unrelated to the ongoing operation of the business in the ordinary course. non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. Non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share have been reconciled to the nearest GAAP measure in the tables following the financial statements in this press release.

About VP-102

Verrica’s lead product candidate, VP-102, is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin (0.7% w/v) delivered via a single-use applicator that allows for precise topical dosing and targeted administration. If approved, VP-102 could potentially be the first product approved by the FDA to treat molluscum contagiosum — a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. Verrica expects to resubmit the NDA for VP-102 for the treatment of molluscum in the first quarter of 2023 and in its resubmission will seek conditional approval to market VP-102 in the United States under the brand name YCANTH. In addition, Verrica has successfully completed a Phase 2 study of VP-102 for the treatment of common warts and a Phase 2 study of VP-102 for the treatment of external genital warts.

About Molluscum Contagiosum (Molluscum)

There are currently no FDA-approved treatments for molluscum, a highly contagious viral skin disease that affects approximately six million people — primarily children — in the United States. Molluscum is caused by a pox virus that produces distinctive raised, skin-toned-to-pink-colored lesions that can cause pain, inflammation, itching and bacterial infection. It is easily transmitted through direct skin-to-skin contact or through fomites (objects that carry the disease like toys, towels or wet surfaces) and can spread to other parts of the body or to other people, including siblings. The lesions can be found on most areas of the body and may carry substantial social stigma. Without treatment, molluscum can last for an average of 13 months, and in some cases, up to several years.