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Bellicum Reports First Quarter 2022 Financial Results and Provides Operational Update

On May 12, 2022 Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported financial results for the first quarter 2022 and provided an operational update (Press release, Bellicum Pharmaceuticals, MAY 12, 2022, View Source [SID1234614370]).

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"I am pleased with the growing momentum in patient recruitment and enrollment after recent COVID-19-related delays at our sites," said Rick Fair, President and Chief Executive Officer. "We remain on track to report results from our ongoing BPX-601 and BPX-603 trials early next year. I appreciate our team’s and investigators’ hard work and commitment to execute to plan in 2022."
Program Highlights and Current Updates

BPX-601 GoCAR-T
•Enrollment in the Phase 1/2 dose escalation clinical trial in patients with previously treated metastatic castration-resistant prostate cancer (mCRPC) is ongoing. The company expects to present a data update on BPX-601 in the first quarter of 2023.

BPX-603 GoCAR-T
•Enrollment is ongoing in the Phase 1/2 clinical trial for BPX-603 in patients with solid tumors that express human epidermal growth factor 2 (HER2), including breast, endometrial, ovarian, gastric, and colorectal cancers. The company expects to present a data update on BPX-603 in the first half of 2023.

Financial Results for the First Quarter 2022

R&D Expenses: Research and development expenses were $4.5 million for the first quarter 2022, compared to $6.5 million for the first quarter 2021. The decrease in R&D expenses for the first quarter 2022 was primarily due to reduced expenses related to rivo-cel activities, a discontinued development program.

G&A Expenses: General and administrative expenses were $1.5 million in the first quarter 2022 compared to $2.0 million for the comparable period in 2021. The decrease in G&A expenses for the first quarter 2022 compared to the first quarter 2021 was primarily due to reduced share-based compensation expense.

Loss from Operations: Bellicum reported a loss from operations of $5.9 million for the first quarter 2022, compared to $8.9 for the comparable period in 2021.

Net Income/Loss: Bellicum reported a net loss of $7.6 million for the first quarter 2022, compared to a net loss of $11.3 million for the first quarter 2021. The results included a loss from the change in fair value of warrant derivative liabilities of $1.6 million for the first quarter of 2022, which was primarily driven by an increase in our stock price over the first quarter of 2022.

Shares Outstanding: As of May 9, 2022, Bellicum had 8,609,661 shares of common stock and 452,000 shares of preferred stock outstanding. Each share of preferred stock is convertible into 10 shares of common stock.

Cash Position and Guidance: Bellicum reported cash and cash equivalents and restricted cash totaling
$41.3 million as of March 31, 2022, compared to $47.7 million as of December 31, 2021.

Phio Pharmaceuticals Reports First Quarter 2022 Financial Results and Provides Business Update

On May 12, 2022 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company developing the next generation of therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported its financial results for the quarter ended March 31, 2022 and provided a business update (Press release, Phio Pharmaceuticals, MAY 12, 2022, View Source [SID1234614369]).

"We are pleased enrollment is open for our first-in-human clinical trial for PH-762 at the Gustave Roussy Institute, one of the largest cancer centers in Europe. This study will evaluate the safety, tolerability, pharmacokinetics and checkpoint anti-tumor activity of PH-762 in a neoadjuvant setting in subjects with advanced melanoma. The clinical study will feature a dose escalation of PH-762 with top-line data from the first group of patients expected in the first quarter of 2023," said Dr. Geert Cauwenbergh, Principal Executive Officer of Phio. "In addition, the new preclinical data we recently presented at the AACR (Free AACR Whitepaper) Annual Meeting shows the potential of PH-894 to be used in treating patients who do not respond to anti-PD-1 therapy, or patients who progress after initially responding to treatment with checkpoint inhibitors. The reaction of the investment community when this data was presented, reinforces the relevance of a compound like PH-894, an INTASYL compound specifically targeting BRD4, in patients who may not respond or relapse after PD-1 therapy. We expect to finalize IND-enabling studies for PH-894 in the second half of 2022," concluded Dr. Cauwenbergh.

Quarter in Review and Recent Corporate Updates

Enrollment open for the Company’s Phase 1b clinical study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of PH-762 in a neoadjuvant setting in subjects with advanced melanoma.
Presented new in vivo data at the AACR (Free AACR Whitepaper) Annual Meeting 2022 that provide a strong rationale for the clinical use of PH-894, a BRD4-targeting, self-delivering RNAi, as a monotherapy, as well as in combination with systemic PD-1 therapy.
Continue to develop PH-3861, a dual-targeting INTASYL towards PD-1 and BRD4. Last year this program reported data that show PH-3861 elicited complete cure of tumors in an in vivo hepatoma model and outperformed the efficacy of the small molecule and antibody control treatments toward the same targets. In addition, local INTASYL therapy was shown to induce a systemic anti-tumor response with clearance of untreated distal tumors.
Upcoming Pipeline Milestones

Expect to finalize IND-enabling studies for PH-894 in the second half of 2022.
On track to report top-line data from the first group of patients with advanced melanoma in the clinical trial for PH-762 in the first quarter of 2023.
Additional data publications on the Company’s pipeline programs.
Financial Results

Cash Position

At March 31, 2022, the Company had cash of $20.5 million as compared with $24.1 million at December 31, 2021. The Company expects its current cash will be sufficient to fund currently planned operations to the second quarter of 2023.

Research and Development Expenses

Research and development expenses were approximately $1.6 million for the quarter ended March 31, 2022, compared with approximately $2.4 million for the quarter ended March 31, 2021. The decrease was primarily due to the preclinical studies and manufacturing costs to support the Company’s clinical trial with PH-762, which were completed in the prior year period, offset by increases in CRO costs in preparation for the start of the Company’s clinical trial with PH-762 and personnel-related expenses due to an increase in headcount as compared to the prior year period.

General and Administrative Expenses

General and administrative expenses were approximately $1.1 million for the quarter ended March 31, 2022, compared with approximately $1.2 million for the quarter ended March 31, 2021. The decrease was primarily due to decreases in legal and patent fees offset by an increase in stock-based compensation expense.

Net Loss

Net loss was $2.6 million, or $0.19 per share, for the quarter ended March 31, 2022, compared with $3.4 million, or $0.32 per share, for the quarter ended March 31, 2021. The decrease in net loss was primarily attributable to the decrease in research and development expenses as described above.

Checkmate Pharmaceuticals Announces First Quarter 2022 Financial Results and Provides Business Update

On May 12, 2022 Checkmate Pharmaceuticals, Inc. (Nasdaq: CMPI) ("Checkmate"), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, reported first quarter 2022 financial results and provided a business update (Press release, Checkmate Pharmaceuticals, MAY 12, 2022, View Source [SID1234614368]).

"We remain focused on the execution of the clinical program for vidutolimod and are delighted with the opportunity to become part of Regeneron, who will help to accelerate the development of vidutolimod as a potential novel treatment for multiple tumor types," said Alan Bash, President and Chief Executive Officer of Checkmate. "This is an exciting opportunity for all stakeholders as we bring this innovative medicine forward and work to make a meaningful difference for patients with difficult to treat cancers."

Recent Business Updates

On April 19, 2022, Regeneron Pharmaceuticals, Inc. and Checkmate Pharmaceuticals, Inc. announced a definitive agreement for the acquisition of Checkmate by Regeneron at an all-cash price of $10.50 per share of Checkmate common stock. The proposed acquisition values Checkmate at a total equity value of approximately $250 million. On May 2, 2022, Scandinavian Acquisition Sub, Inc., a wholly owned subsidiary of Regeneron, commenced a tender offer for all of the outstanding shares of Checkmate common stock. The transaction is expected to close in mid-2022.
First Quarter 2022 Financial Results

Research and development expenses (R&D): R&D expenses for the first quarter of 2022 were $11.6 million, compared to $10.4 million for the same period in the prior year. This increase was primarily driven by higher third-party contract research organization, internal personnel and consulting costs related to our ongoing clinical trials. First quarter 2021 expenses included the impact of a $2.0 million milestone payment to Kuros in March 2021, which became payable upon initiating dosing of the first patient in a Phase 2 clinical trial. There was no corresponding expense in Q1 2022.
General and administration expenses (G&A): G&A expenses for the first quarter of 2022 were $4.2 million, compared to $3.8 million for the same period in the prior year. This increase was primarily attributable to professional fees incurred in Q1 2022 in connection with the proposed acquisition by Regeneron and recruiting costs associated with hiring a chief executive officer in March 2022.
Cash, cash equivalents and investments: Cash, cash equivalents and available-for-sale investments were $60.1 million as of March 31, 2022.

Checkpoint Therapeutics Reports First Quarter 2022 Financial Results and Recent Corporate Highlights

On May 12, 2022 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported financial results for the first quarter ended March 31, 2022 and recent corporate highlights (Press release, Checkpoint Therapeutics, MAY 12, 2022, View Source [SID1234614367]).

James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "The positive topline results generated in the first quarter from our ongoing registrational trial of cosibelimab in metastatic cutaneous squamous cell carcinoma ("cSCC") laid the foundation for a potentially transformational year for our lead immunotherapy product candidate and for our company as a whole. We remain on track to submit our U.S. Biologics License Application ("BLA") for cosibelimab later this year and continue to evaluate partnership opportunities for the potential commercialization of cosibelimab in Europe and other key territories worldwide." Mr. Oliviero continued, "Our focus remains on advancing our pipeline of potentially life-saving novel oncology therapies with the goal of expanding patient access globally through a disruptive pricing strategy, beginning with the $30 billion and growing PD-(L)1 market."

Recent Corporate Highlights:

In January 2022, Checkpoint announced positive topline results from the ongoing registration-enabling clinical trial evaluating the safety and efficacy of its anti-PD-L1 antibody, cosibelimab, administered as a fixed dose of 800 mg every two weeks in patients with metastatic cSCC. The study met its primary endpoint, with cosibelimab demonstrating a confirmed objective response rate of 47.4% (95% CI: 36.0, 59.1) based on independent central review of 78 patients enrolled in the metastatic cSCC cohort using Response Evaluation Criteria in Solid Tumors version 1.1 criteria. Checkpoint intends to submit a BLA for cosibelimab in late 2022, followed by a Marketing Authorization Application submission in Europe and other territories worldwide. With a potentially favorable safety profile versus anti-PD-1 therapy and a plan to commercialize at a substantially lower price, Checkpoint believes cosibelimab has the potential to be a market disruptive product in the $30 billion and growing PD-(L)1 class.
In April 2022, Checkpoint announced that the results of its pivotal trial of cosibelimab in cSCC were selected for poster presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held at McCormick Place, in Chicago, June 3-7, 2022.
Financial Results:

Cash Position: As of March 31, 2022, Checkpoint’s cash and cash equivalents totaled $41.5 million, compared to $54.7 million at December 31, 2021, a decrease of $13.2 million.
R&D Expenses: Research and development expenses for the first quarter of 2022 were $14.7 million, compared to $4.2 million for the first quarter of 2021, an increase of $10.5 million. Research and development expenses for the first quarters of 2022 and 2021 each included $0.2 million of non-cash stock expenses.
G&A Expenses: General and administrative expenses for the first quarter of 2022 were $2.2 million, compared to $2.4 million for the first quarter of 2021, a decrease of $0.2 million. General and administrative expenses for the first quarter of 2022 included $0.7 million of non-cash stock expenses, compared to $1.2 million for the first quarter of 2021.
Net Loss: Net loss attributable to common stockholders for the first quarter of 2022 was $16.8 million, or $0.20 per share, compared to a net loss of $6.5 million, or $0.09 per share, in the first quarter of 2021. Net loss for the first quarter of 2022 included $0.9 million of non-cash stock expenses, compared to $1.4 million for the first quarter of 2021.

Ensysce Biosciences Provides Business Update and Reports First Quarter 2022 Financial Results

On May 12, 2022 Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ: ENSC, OTC: 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 first quarter 2022 (Press release, Leisure Acquisition, MAY 12, 2022, View Source [SID1234614365]).

Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "The first few months of 2022 are off to an exciting start, evident in the most recent clinical results from trials PF614-102 and PF614-MPAR-101. As we progress on our studies and clinical trials, we are closer to realizing our mission – providing abuse and overdose protection where needed. I look forward to our upcoming corporate update call next week to discuss the recent results from the trials, especially regarding the longer-lasting profile of PF614 and the encouraging initial data from our overdose protection study. Additionally, we expect the Bioequivalence (BE) trial data of our TAAP opioid, PF614, to be available prior to the end of the second quarter, positioning PF614 as our first commercial candidate and demonstrating progress towards our goal to bring a unique pipeline of products to the market."

TAAPTM (Opioid Abuse Deterrent Program) Updates

●On May 5, 2022, the Company announced clinical trial results from trial PF614-102 confirming the safety and longer-lasting profile of PF614 versus Oxycontin.

●The results of the study show the longer-lasting half-life of PF614 versus OxyContin as seen in the prior Phase 1 single-ascending dose study of PF614 oral solution versus OxyContin. We believe this data confirms the findings from our Phase 1 study that demonstrate PF614 should provide true twice-daily dosing.

●The safety data for the study also showed that PF614 performed similarly to OxyContin with no serious treatment emergent adverse events recorded.

The second part of the PF614-102 study, the bioequivalence (BE) arm, continues to be analyzed and as reported previously, we anticipate that this BE data will be available by the end of the second quarter of 2022. The Company believes that the data will support the 505(b)(2) regulatory path for clinical development of PF614, an abbreviated pathway to FDA approval.

●Human abuse liability (HAL) studies to determine labeling claims for PF614 are scheduled to initiate in the second quarter of 2022.

●PF614 is designed using the abuse protective platform TAAP, Trypsin Activated Abuse Protection, a chemical modification which inactivates the active ingredient in Ensysce’s opioid products, including PF614, until swallowed and exposed to the enzyme trypsin in the digestive system. Our TAAP platform, which we believe provides abuse protection and resistance to manipulation and other forms of recreational drug abuse, should also control the rate of release of the active opioid.

MPARTM (Opioid Abuse Deterrent and Overdose Protection Program) Updates

●On May 5, 2022, the Company announced initial results from trial PF614-MPAR-101, providing first human data showing the potential for overdose protection with MPAR, Multi-Pill Abuse Resistance.

●This data demonstrated how the combination product PF614-MPAR could reduce the trypsin activation and reduce the release of oxycodone in a simulated overdose situation. It also demonstrated the PF614 in the systemic circulation (simulated injection) did not convert to oxycodone. We believe this is the first step to identifying the first MPAR drug product that will be marketed in the coming years.

●The study is continuing with additional subjects enrolling to receive PF614 and trypsin inhibitor nafamstat in various combinations through the third quarter of 2022. Safety and pharmacokinetic results are expected by the end of the third quarter 2022.

Financial Results

●Cash – Cash and cash equivalents were $8.4 million as of March 31, 2022, as compared to $12.3 million at December 31, 2021. Cash used in operating activities for the first quarter of 2022 totaled $3.4 million, an increase from $0.5 million in the first quarter of 2021 that primarily resulted from the clinical advancement of our product candidates and increased costs related to operating as a public company.

●Federal Grants – Funding from federal grants was $0.6 million for the first quarter of 2022 compared to $0.3 in the comparable year ago quarter. Funding increased by $0.4 million under the MPAR Grant, offset by a decrease of $0.1 million under the OUD Grant, due to the timing of research activities eligible for funding.

●Research & Development Expenses – R&D expenses were $3.1 million for the first quarter of 2022 compared to $0.3 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 $2.3 million for the first quarter of 2022 compared to $0.5 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 and director and officer insurance expenses.

●Other Income (Expense) – Total other income (expense), was income of $3.9 million in the first quarter of 2022 and expense of $0.4 million in the first quarter of 2021. The income in the 2022 period is due to non-cash valuation adjustments of current obligations of the Company. 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 first quarter of 2022 was $1.0 million compared to net loss of $0.9 million for the comparable year ago period. As we are a clinical stage biotech company, our research and development of, and regulatory approvals for, our product candidates are expected to continue, resulting in expected losses for the foreseeable future.

Additional Company Highlights

●On February 8, 2022, the Company added further depth to its Board of Directors with the appointment of Lee Rauch.

●On April 18, 2022, the Company announced the appointment of Dr. Nily Osman as Chief Medical Officer.

Corporate Update Conference Call

Management will host a corporate update conference call on Tuesday, May 17, 2022, at 11:00am ET to provide a corporate update and review the recently discussed results 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 Tuesday, June 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 13729812.