Processa Pharmaceuticals Announces First Quarter 2022 Financial Results and Provides Corporate Update

On May 12, 2022 Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) ("Processa" or the "Company"), a clinical stage company developing drugs for patients who have unmet medical conditions that require better treatment options to improve a patient’s survival and/or quality of life, reported financial results for the quarter ended March 31, 2022, and provided an update on its clinical programs (Press release, Processa Pharmaceuticals, MAY 12, 2022, View Source [SID1234614356]).

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Dr. David Young, CEO and chairman of Processa, commented, "We are on track to get important data from all our clinical programs over the remainder of this year that will elucidate the path to registration for these programs that each have a market that could exceed $1 billion.

The amended protocol for Next Generation Capecitabine will provide insights into the de novo formation of DPD by mid-summer and allow us to get to the MTD by year-end;
Our expanded outreach to find and enroll patients in the PCS499 uNL trial has identified new potential patients to complete enrollment for our interim analysis cohort mid-summer and interim results by year-end;
Enrollment in PCS12852 is going well and is expected to fully enroll patients and provide top line results before the end of the year; and
We expect to complete the initial development on the macromolecule assays that will be evaluated as potential biomarkers for PCS3117 and confirm our Regulatory Path with FDA by the end of the year."
Financial Results for the Quarter Ended March 31, 2022

We continue to manage our cash efficiently and had a cash balance of $14.4 million at March 31, 2022. We believe this will allow us to complete our three on-going clinical trials and fund our operations into the third quarter of 2023. During the three months ending on March 31, 2022 we spent cash of $1.8 million in our clinical trials and operations.

For the three months ended March 31, 2022, we reported a net loss of $3.2 million, or $0.20 per share compared to a net loss of $2.1 million, or $0.14 per share for the same period of 2021. The increase in our net loss relates primarily to increased clinical trial costs we incurred.

During the three months ended March 31, 2022, we incurred research and development expenses totaling $2.0 million compared to $1.5 million for the same period in 2021. The increase in our R&D expenditures was primarily due to costs we incurred in our active clinical trials. Our general and administrative expenses totaled $1.2 million for the three months ended March 31, 2022 compared to $717 thousand for the same period in 2021. The increase related primarily to increases in non-cash stock-based compensation along with other operating and consulting costs. We allocated $829 thousand of non-cash compensation costs between our R&D and G&A expenses.

As of March 31, 2022, we had 15.8 million shares of common stock outstanding.

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Entry into a Material Definitive Agreement

On May 12, 2022, Athersys, Inc. (the "Company," "we," "us" or "our") reported that entered into a common stock purchase agreement (the "Purchase Agreement") with Aspire Capital Fund, LLC ("Aspire Capital"), which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $100 million of shares of the Company’s common stock over the 24-month term of the Purchase Agreement (Filing, 8-K, Athersys, MAY 12, 2022, View Source [SID1234614373]).

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Concurrently with entering into the Purchase Agreement, the Company also entered into a registration rights agreement with Aspire Capital (the "Registration Rights Agreement"), pursuant to which the Company agreed to file with the Securities and Exchange Commission a prospectus supplement to the Company’s effective shelf registration statement on Form S-3 (File No. 333-238810) registering all of the shares of common stock that may be offered to Aspire Capital from time to time under the Purchase Agreement.

Under the Purchase Agreement, we have the right, in our sole discretion, to present Aspire Capital with a purchase notice (each, a "Purchase Notice"), directing Aspire Capital (as principal) to purchase up to 200,000 shares of our common stock per trading day, provided that the aggregate price of such purchase shall not exceed $500,000 per trading day, up to $100 million of our common stock in the aggregate. We and Aspire Capital also may mutually agree to increase the number of shares that may be sold to as much as an additional 2,000,000 shares per business day. The purchase price per share pursuant to such Purchase Notice (the "Purchase Price") is the lower of (i) the lowest sale price for the Company’s common stock on the date of sale and (ii) the arithmetic average of the three lowest closing sale prices for the Company’s common stock during the ten consecutive business days ending on the business day immediately preceding the purchase date of those securities. The applicable Purchase Price will be determined prior to delivery of any Purchase Notice.

In addition, on any date on which we submit a Purchase Notice to Aspire Capital in an amount of at least 100,000 shares, we also have the right, in our sole discretion, to present Aspire Capital with a volume-weighted average price purchase notice (each, a "VWAP Purchase Notice") directing Aspire Capital to purchase an amount of the Company’s common stock equal to a percentage (not to exceed 30%) of the aggregate shares of common stock traded on The Nasdaq Capital Market on the next business day (the "VWAP Purchase Date"), subject to a maximum number of shares determined by the Company (the "VWAP Purchase Share Volume Maximum"). The purchase price per share pursuant to such VWAP Purchase Notice (the "VWAP Purchase Price") shall be the lower of (i) the closing sale price on the date of sale and (ii) 95% of the volume weighted average price for the Company’s common stock traded on The Nasdaq Capital Market on (a) the VWAP Purchase Date if the aggregate shares to be purchased on that date does not exceeded the VWAP Purchase Share Volume Maximum and the sale price of our common stock has not fallen below the price set by us in the VWAP Purchase Notice (the "VWAP Minimum Price Threshold") (to be appropriately adjusted for any reorganization, recapitalization, non-cash dividend stock split, reverse stock split or other similar transaction) or (b) the portion of such business day until such time as the aggregate shares to be purchased will equal the VWAP Purchase Share Volume Maximum. Further, if the sale price of our common stock falls on the VWAP Purchase Date below the greater of (i) 90% of the closing price of our common stock on the business day immediately preceding the VWAP Purchase Date and (ii) the VWAP Minimum Price Threshold, the VWAP Purchase Price will be determined using the percentage in the VWAP Purchase Notice of the total shares traded for such portion of the VWAP Purchase Date prior to the time that the sale price of our common stock fell below the VWAP Minimum Price Threshold and the volume weighted average price of our common stock sold during such portion of the VWAP Purchase Date prior to the time that the sale price of our common stock fell below the VWAP Minimum Price Threshold.

The respective prices and share numbers in the preceding paragraphs shall be appropriately adjusted for any reorganization, recapitalization, stock dividend, stock split, reverse stock split or other similar transaction.

The Purchase Agreement provides that the Company and Aspire Capital shall not effect any sales under the Purchase Agreement on any purchase date where the closing sale price of the Company’s common stock is less than $0.25 per share. There are no trading volume requirements or restrictions under the Purchase Agreement, and we will control the timing and amount of any sales of our common stock to Aspire Capital. Aspire Capital has no right to require any sales by us, but is obligated to make purchases from us as we direct in accordance with the Purchase Agreement. The Company may deliver multiple Purchase Notices and VWAP Purchase Notices to Aspire Capital from time to time during the term of the Purchase Agreement, so long as the most recent purchase has been completed. There are no limitations on use of proceeds, financial or business covenants, restrictions on future fundings, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement. The Purchase Agreement may be terminated by us at any time, at our discretion, without any penalty or cost to us. Also, Aspire Capital has agreed that neither it nor any of its agents, representatives and affiliates shall engage in any direct or indirect short-selling or hedging, which establishes a net short position with respect to our common stock during any time prior to the termination of the Purchase Agreement.

The Purchase Agreement provides for events of default, upon the occurrence of which Aspire Capital may terminate the Purchase Agreement. Such events of default include, without limitation:

•the lapse, or unavailability to Aspire Capital for the sale of shares of the Company’s common stock, of any registration statement that is required to be maintained effective pursuant to the terms of the Registration Rights Agreement, subject to specified cure periods;
•the suspension from trading or failure of the Company’s common stock to be listed on a Principal Market (as defined in the Purchase Agreement) for a period of three consecutive business days;
•the delisting of the Company’s common stock from the Principal Market, provided the Company’s common stock is not immediately thereafter trading on the New York Stock Exchange, the NYSE American, The Nasdaq Global Select Market, The Nasdaq Global Market or The Nasdaq Capital Market;
•the failure for any reason by the Company’s transfer agent to issue shares to Aspire Capital within five business days after the applicable purchase date that Aspire Capital is entitled to receive such shares;
•if any of the current Executive Officers (as defined in Section 16 of the Securities Exchange Act of 1934) of the Company ceases to be an Executive Officer or full-time employee of the Company for any reason;
•if any proceeding against the Company is commenced pursuant to or within the meaning of any bankruptcy law; and
•any breach by the Company of the representations, warranties, covenants or other term or condition contained in the Purchase Agreement or any related agreements that would reasonably be expected to have a material adverse effect, except, in the case of a breach of a covenant which is reasonably curable, only if such breach continues for a period of at least five business days.

The foregoing is a summary description of certain terms of the Purchase Agreement and the Registration Rights Agreement. For a full description of all terms, please refer to copies of the Purchase Agreement and the Registration Rights Agreement that are filed herewith as Exhibits 10.1 and 10.2, respectively, to this Current Report on Form 8-K and are incorporated herein by reference. All readers are encouraged to read the entire text of the Purchase Agreement and the Registration Rights Agreement.

GT Biopharma to Participate at H.C. Wainwright Hybrid Global Investment Conference

On May 12, 2022 GT Biopharma, Inc. (NASDAQ: GTBP), an immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary tri-specific natural killer (NK) cell engager, TriKE protein biologic technology platform, reported that management will present at H.C. Wainwright’s Hybrid Global Investment Conference (Press release, GT Biopharma, MAY 12, 2022, https://ir.gtbiopharma.com/news/detail/252/gt-biopharma-to-participate-at-h-c-wainwright-hybrid-global-investment-conference [SID1234614389]). The conference will take place May 23-26, 2022 at the Fontainebleau, Miami Beach Hotel, Miami Beach, Florida.

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H.C. Wainwright Global Investment Conference – May 23-26, 2022

If you are interested in arranging a 1×1 meeting request with management, please contact your bank conference representative. To access the archived recording for replay, please see the Presentations section of GT Biopharma’s corporate website.

Sapience Therapeutics Announces Poster Presentation on ST101 Phase 1 Study Results at the American Society of Clinical Oncology (ASCO) Annual Meeting 2022

On May 12, 2022 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported that it will present Phase 1 study results from its lead program, ST101, during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 3-7, 2022 in Chicago, IL (Press release, Sapience Therapeutics, MAY 12, 2022, View Source [SID1234614409]).

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Details of the poster presentation are as follows:

Abstract Number: 3014
Title: Efficacy proof-of-concept from a phase 1 study of a novel therapeutic peptide, ST101, targeting the oncogenic transcription factor C/EBPβ in patients with refractory solid tumors
Session Title/Track: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Session Type: Poster Discussion Session

Abstracts and full session details, when available, can be accessed through the ASCO (Free ASCO Whitepaper) meeting planner: Abstracts | ASCO (Free ASCO Whitepaper) Annual Meeting

About ST101
ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). ST101-101 is an open-label, two-part, Phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 in patients with advanced solid tumors. The study consists of two phases: a Phase 1 dose escalation/regimen exploration phase and a Phase 2 expansion phase. In the ongoing dose escalation study, ST101 has demonstrated clinical proof-of-concept with a durable RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. In the ongoing Phase 2 dose expansion part of the study, Sapience is actively enrolling patients with GBM, metastatic cutaneous melanoma, locally advanced or metastatic hormone-receptor positive breast cancer and castration-resistant prostate cancer. ST101 has been granted Fast Track designation for recurrent GBM and advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy, as well as orphan designations from the FDA for advanced melanoma, glioma and AML, and from the European Commission for the treatment of glioma.

Aura Biosciences Reports First Quarter 2022 Financial Results and Provides Clinical Development and Operational Highlights

On May 12, 2022 Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported financial results for the first quarter ended March 31, 2022, and provided clinical development and operational highlights (Press release, Aura Biosciences, MAY 12, 2022, View Source [SID1234614427]).

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"We continue to advance the AU-011 overall development program and look forward to several upcoming clinical milestones, in the second half of this year," said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. "We remain on track with our Phase 2 suprachoroidal study in early stage choroidal melanoma and plan to finalize a decision on the route of administration and initiate our pivotal program before the end of the year. Beyond primary choroidal melanoma, we continue to build our ocular oncology franchise and we are on track to file an Investigational New Drug application for choroidal metastases, with pre-clinical data presented at ARVO last week. Lastly, we will be initiating our Phase 1 trial in non-muscle invasive bladder cancer, with multiple clinical sites in the US. While we remain focused on preparing for our pivotal trial in choroidal melanoma, we are also excited by the prospect of leveraging our VDC therapies across multiple oncology indications and providing new treatment options for patients with life threatening cancers."

Recent Pipeline Developments

AU-011 is being developed for the treatment of early-stage choroidal melanoma (CM), a life-threatening rare disease with no approved drugs. Orphan Drug Designation was recently granted to AU-011 by the European Commission for the treatment of uveal melanoma (includes CM). AU-011 was previously granted Orphan Drug and Fast Track Designations for this indication by the U.S. Food and Drug Administration (FDA). Aura plans to select the route of administration and treatment regimen to initiate the pivotal program in CM in the second half of 2022.

Beyond primary CM, we continue to build our ocular oncology franchise with choroidal metastases being the second potential ocular indication.

Abstract highlighting AU-011’s efficacy as a single agent and as a combination therapy with checkpoint inhibitors has been selected for publication at the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The abstract, titled "A novel virus-like drug conjugate (VDC) in combination with immune checkpoint inhibitors for the treatment of primary tumors and distant metastasis" will be published as part of the Session titled "Developmental Therapeutics – Immunotherapy" and will be available on the ASCO (Free ASCO Whitepaper) website on Thursday, May 26, 2022, at 5:00 pm. ET.

Preclinical data highlighting AU-011 anti-tumor activity was presented at the 2022 Association of Research in Vision and Ophthalmology (ARVO) Annual Meeting. Preclinical results highlighted AU-011’s targeted cytotoxicity in tumor cells derived from the most common cancer types known to metastasize to the choroid in the eye. AU-011 showed dose dependent activity in vivo using cognate tumor models. These results support further evaluation of AU-011 as a potential treatment for choroidal metastases, the most common type of intraocular malignancy in adults. Aura plans to file an Investigational New Drug (IND) application with the FDA in the second half of 2022 for choroidal metastases.

Leveraging the broad tumor targeting capabilities of the VDC platform, Aura is planning to pursue clinical development of AU-011 in non-muscle invasive bladder cancer (NMIBC).

The AU-011 mechanism of action supports the opportunity for use as a first-line treatment of NMIBC, an area of high unmet need with no approved targeted therapies. The planned Phase 1 trial will evaluate the safety and early proof of mechanism, exploring distribution, local necrosis and evidence of immune activation. Aura expects to initiate the trial in the second half of 2022 with initial Phase 1 data in 2023.

Aura is investigating additional potential indications for AU-011.

Preclinical data highlighting the ability to target a broad number of tumor types was presented as part of the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The data that was presented at the AACR (Free AACR Whitepaper) annual meeting support AU-011’s potential to target associated heparan-sulfate proteoglycans that are overexpressed on the tumor cell surface. Activity was observed in every tumor type tested, indicating that there are numerous solid tumors that AU-011 can target and potentially treat, particularly those derived from neural or epithelial lineages. The AACR (Free AACR Whitepaper) annual meeting was held April 8-13, 2022 in New Orleans, LA.
First Quarter 2022 Financial Results

As of March 31, 2022, Aura had cash and cash equivalents and marketable securities totaling $133.3 million. Aura believes its current cash and cash equivalents and marketable securities are sufficient to fund its operations into 2024.
Research and development expenses increased to $8.3 million for the three months ended March 31, 2022 from $4.2 million for the three months ended March 31, 2021, primarily due to ongoing manufacturing and development costs for AU-011 and higher personnel expenses from growing headcount.
General and administrative expenses increased to $4.5 million for the three months ended March 31, 2022 from $1.7 million for the three months ended March 31, 2021. General and administrative expenses include $1.0 million and $0.1 million of stock-based compensation for the three months ended March 31, 2022 and 2021, respectively. The increase was primarily driven by personnel expenses, as well as increases in general corporate expenses related to operating as a public company.
Net loss for the three months ended March 31, 2022 was $12.8 million compared to $5.9 million for the three months ended March 31, 2021.