On November 10, 2022 Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported financial results for the second quarter 2022 and provided an operational update (Press release, Bellicum Pharmaceuticals, NOV 10, 2022, View Source [SID1234623724]).

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"We are encouraged by the progress we are making in our patient enrollment efforts for the BPX-601 and BPX-603 trials despite a national fludarabine shortage, and are on track to present data updates for both programs in the first half of 2023," said Rick Fair, President and Chief Executive Officer. "We are also excited about new data from the Baylor College of Medicine supporting the potential benefit of CaspaCIDe in resolving the adverse events associated with cell therapies, and remain committed to expanding CaspaCIDe use through collaborations with other developers of cell therapies."
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 provide interim data 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 announce interim data from this trial in the first half of 2023.

Fludarabine Shortage
•In May 2022, the FDA announced a shortage of fludarabine in the U.S. that is affecting the company’s clinical trial sites. Fludarabine is a chemotherapeutic agent used as part of a lymphodepletion regimen administered to patients prior to receiving CAR-T cells and is required as part of the protocols in the BPX-601 and BPX-603 Phase 1/2 trials. Some of the BPX-601 and BPX-603 trial sites have been unable to procure fludarabine, or have had restrictions placed on fludarabine use, which has affected enrollment and patient dosing at these trial sites. The company has begun to procure a fludarabine supply for patients at these sites and expects to receive fludarabine and resume dosing of patients at these sites in the fourth quarter of 2022.

CaspaCIDe (Inducible Caspase-9)
•At the 54th annual meeting of the International Society of Paediatric Oncology (SIOP Congress September 28 to October 1, 2022), David Steffin, M.D., and colleagues from the Center for Cell and Gene Therapy at the Baylor College of Medicine reported initial findings from a study of GPC3 CAR-T cells co-expressing IL-15 and inducible caspase-9 in children with liver cancer. Infusion of these CAR-T cells into a 20-year-old hepatocellular carcinoma (HCC) patient led to robust lymphocyte expansion associated with grade 4 cytokine release syndrome not controlled by IL-6, IL-1 or tumor necrosis factor-alpha inhibition. The patient’s symptoms were rapidly relieved by administration of rimiducid to trigger inducible caspase-9. Anti-tumor activity in the primary liver lesion and lung metastases four weeks after CAR-T cell infusion was reported.

Financial Results for the Third Quarter 2022

Revenues: Bellicum reported revenue of $1.0 million for the three and nine months ended September 30, 2022, compared to $5.0 million and $5.7 million for the same periods in 2021. Revenue in 2022 was from licensing, and in 2021 from licensing and from sale of rimiducid for use in clinical trials.

R&D Expenses: Research and development expenses were $6.9 million and $16.4 million for the three and nine months ended September 30, 2022, respectively, compared to $6.3 million and $19.5 million for the three and nine months ended September 30, 2021, respectively. The increase for the quarter was primarily due to increased R&D headcount and associated personnel costs. At the end of the third quarter of 2022, Bellicum had 11 full time equivalent R&D employees, compared to 5 at the end of the third quarter of 2021. The decrease for the three quarters in 2022 compared to 2021, was due to continued reduction of expenses related to rivo-cel activities and patient enrollment delays in ongoing clinical trials.

G&A Expenses: General and administrative expenses were $1.3 million and $4.2 million for the three and nine months ended September 30, 2022, respectively, compared to $1.7 million and $5.5 million for the three and nine months ended September 30, 2021, respectively. The decrease in G&A expenses for the third quarter 2022 was primarily due to reduced personnel costs, share-based compensation expenses and depreciation expenses.

Loss from Operations: Bellicum reported a loss from operations of $7.2 million and $19.6 million for the three and nine months ended September 30, 2022, respectively, compared to a loss from operations of $3.0 and $19.8 million for the three and nine months ended September 30, 2021, respectively.

Net Income/Loss: Bellicum reported a net loss of $7.2 million for the three months ended September 30, 2022, and a net loss of $18.8 million for the nine months ended September 30, 2022, compared to a net income of $1.2 million and a net loss of $12.2 million for the three and nine months ended September 30, 2021, respectively

Shares Outstanding: As of August 5, 2022, Bellicum had 8,613,527 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: Bellicum reported cash and cash equivalents totaling $28.8 million as of September 30, 2022, compared to cash, cash equivalents and restricted cash totaling $47.7 million as of December 31, 2021.

On November 10, 2022 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that financial results for the three-month period ended September 30, 2022 and provided a corporate update (Press release, Spectrum Pharmaceuticals, NOV 10, 2022, View Source [SID1234623723]).

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Third Quarter 2022 and Recent Business Update

•Launched ROLVEDON (eflapegrastim-xnst) injection for adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia into an estimated approximately $2 billion market.

•Closed on debt financing with SLR Capital Partners, LLC (SLR) for a term loan facility of up to $65 million, of which $30 million was funded at closing.

•As of September 30, 2022, the Company had $100.3 million of cash, cash equivalents, and marketable securities available to optimize the ROLVEDON commercial launch and extends the Company’s cash runway through 2024.

•The U.S. Food and Drug Administration’s ("FDA") Oncologic Drugs Advisory Committee ("ODAC") reviewed poziotinib for the treatment of patients with previously treated locally advanced or metastatic non-small cell lung cancer ("NSCLC") harboring HER2 exon 20 insertion mutations and voted 9-4 that the current benefits of poziotinib do not outweigh its risks. The PDUFA date for poziotinib is scheduled for November 24, 2022.

"The approval of ROLVEDON marks a significant accomplishment for Spectrum and our partner Hanmi Pharmaceutical. We are proud that the product became commercially available in October and are excited to be competing in an estimated $2 billion market opportunity. Importantly, we have been preparing for this milestone and have the financial runway to support ROLVEDON in the marketplace," said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. "While we are disappointed by the ODAC vote on poziotinib, we are awaiting the final response from the FDA and will continue to act in the best interest of the Company, our shareholders, and the patients who need our medicines."

Three-Month Period Ended September 30, 2022 (All numbers are from Continuing Operations)
Total research and development expenses were $13.3 million during the quarter, compared to $20.9 million in the same period in 2021. The $7.5 million decrease is primarily attributable to completed program spend associated with ROLVEDON, as well as a decrease in personnel-related expenses of $3.0 million related to the strategic restructuring that began in January 2022.
Selling, General and Administrative expenses were $8.3 million during the quarter, compared to $12.2 million in the same period in 2021. The $4.0 million decrease is primarily due to lower costs associated
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with employee compensation, benefits, and other headcount related expenses related to the reduction of workforce announced in January, as well as decreases in stock-based compensation.
Spectrum recorded a net loss of $21.9 million, or a $0.12 loss per basic and diluted share, in the three-month period ended September 30, 2022, compared to a net loss of $33.1 million, or a $0.21 loss per basic and diluted share, in the comparable period in 2021.
Cash Position and Guidance

The Company had a total cash, cash equivalents, and marketable securities balance of approximately $100.3 million at September 30, 2022.
Conference Call
As previously announced, management will host a conference call as follows:

The webcast will be archived under the "Events and Presentations" section of the Company’s investor relations website.

On November 10, 2022 Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, reported financial results for the third quarter ended September 30, 2022 and provided a business update (Press release, Bolt Biotherapeutics, NOV 10, 2022, View Source [SID1234623722]).

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"In the third quarter, our clinical development team advanced BDC-1001 for patients with HER2-expressing solid tumors through dose-escalation monotherapy and combination studies with Opdivo while exploring biweekly and weekly schedules. We look forward to announcing topline data and our recommended Phase 2 dose for the monotherapy and combination dose-expansion trials during the first quarter of 2023, with full data to be presented at an upcoming scientific conference," said Randall C. Schatzman, Ph.D., Chief Executive Officer of Bolt Biotherapeutics. "We also continue to make strong progress in our proprietary BDC-3042 program, which is progressing through IND-enabling activities supporting initiation of clinical studies in 2023, and our collaboration programs. Our work with strategic partners on new ISAC pipeline programs positions Bolt to continuously innovate targeted immunotherapies with the potential to improve the treatment of cancer. Finally, I’d like to recognize how our talented research and development teams, have established our leadership position in ISACs, as they advance our promising next-generation immuno-oncology therapeutics."

Recent Highlights and Anticipated Milestones

BDC-1001 – The monotherapy and combination dose-escalation trial is on track to complete enrollment by year-end. Topline data, the recommended Phase 2 dose (RP2D), and Phase 2 dose-expansion study design are expected during the first quarter of 2023, with full data to follow later in 2023. Biweekly and weekly dosing regimens of BDC-1001, a HER2-targeting Boltbody immune-stimulating antibody conjugate (ISAC), are currently being evaluated in a Phase 1/2 multi-dose, multi-center study in monotherapy and combination studies with Bristol Myers Squibb’s PD-1 checkpoint inhibitor Opdivo (nivolumab). To date, BDC-1001 has demonstrated a favorable safety profile, changes in plasma and tumor biomarkers consistent with its novel mechanism of action, and signs of durable clinical disease control.

BDC-3042 on track to enter the clinic in 2023 – Investigational New Drug (IND)-enabling activities for BDC-3042, an agonist antibody that stimulates Dectin-2, are on track to support an IND filing and initiation of clinical development in 2023. Preclinical studies demonstrate that Dectin-2 agonist antibodies reprogram tumor-associated macrophages to drive anti-tumor immunity.

Cash, cash equivalents, and marketable securities were $209.6 million as of September 30, 2022 – Cash on hand, coupled with growing collaboration revenues, is expected to fund multiple key milestones and operations through 2025.

Upcoming Events

BDC-3042 poster presentation highlighting new preclinical data will be presented at the 2022 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). Bolt Biotherapeutics’ Justin Kenkel, Ph.D., will present a poster entitled, "BDC-3042: A Dectin-2 agonistic antibody for tumor-associated macrophage-directed immunotherapy."
Authors: Justin Kenkel, Rishali Gadkari, Jess Nolin, Fang Xiao, Po Ho, Cindy Kreder, Laughing Bear Torrez, David Omstead, Katelynn McEachin, Jason Ptacek, Lu Xu, Duy Nguyen, Karla Henning, Steven Chapin, David Dornan, Michael Alonso, Shelley Ackerman

Poster Number: 1348

Presentation Date: Friday, Nov. 11, 2022, 9:00 a.m. – 8:30 p.m. EST, Poster Hall, Boston Convention and Exhibition Center

Stifel 2022 Healthcare Conference. Management will be available for meetings with the investment community on Wednesday, November 16th, 2022, with a corporate presentation at 1:15 p.m. ET in New York, New York.

Third Quarter 2022 Financial Results

Collaboration Revenue – Collaboration revenue was $2.1 million for the third quarter ended September 30, 2022, compared to $0.8 million for the same quarter in 2021. This represents 50% growth over the second quarter of 2022 as Bolt continues to ramp up activities supporting its collaborations. Revenue in 2022 was generated from the services performed under the R&D collaborations with Genmab A/S and Innovent Biologics, Inc.

Research and Development (R&D) Expenses – R&D expenses were $19.0 million for the third quarter ended September 30, 2022, compared to $19.3 million for the same quarter in 2021.

General and Administrative (G&A) Expenses – G&A expenses were $5.5 million for the third quarter ended September 30, 2022, compared to $4.9 million for the same quarter in 2021, primarily due to increases in personnel-related expenses relating to an increase in headcount.

Loss from Operations – Loss from operations was $22.3 million for the third quarter ended September 30, 2022, compared to $23.5 million for the same quarter in 2021.

About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform
Bolt Biotherapeutics’ Boltbody ISAC platform unites the precision of antibodies with the power of the innate and adaptive immune system to reprogram the tumor microenvironment for a productive anti-cancer response. Each Boltbody ISAC candidate comprises a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant. The antibody is designed to target one or more markers on the surface of a tumor cell and the immune stimulant is designed to recruit and activate myeloid cells. Activated myeloid cells initiate a positive feedback loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lowering the activation threshold for an immune response. This increases the population of activated immune system cells in the tumor microenvironment and promotes a robust immune response, with the goal of generating durable therapeutic responses for patients with cancer.

On November 10, 2022 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported financial results for the third quarter ended September 30, 2022, and provided a business update (Press release, Janux Therapeutics, NOV 10, 2022, View Source [SID1234623721]).

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"We recently reached our most important milestone by dosing our first patient. At Janux we operate under the tenet that every day matters for cancer patients, and our ability to rapidly move our lead PSMA-TRACTr into the clinic to provide needed treatments for these patients exemplifies this principle," said David Campbell, Ph.D., President and CEO of Janux.

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

Janux has prioritized its programs to enable sufficient funding to provide key clinical data assessments for its lead programs.

First patient dosed with lead program (JANX007) in first-in-human Phase 1 clinical trial in prostate cancer patients.

The Phase 1 clinical trial is a multi-center, open-label dose escalation trial to evaluate ascending doses of JANX007 in patients with mCRPC. This trial is assessing the safety, tolerability, pharmacokinetic, pharmacodynamic, and the preliminary efficacy of JANX007 as a single agent in adult subjects with mCRPC. For additional information about the trial, please visit clinicaltrials.gov using the identifier NCT05519449.

CGMP manufacturing of EGFR-TRACTr (JANX008) drug substance and drug product has been completed and the material released to support the IND and supply first-in-human clinical trials.

Initiated CGMP manufacturing of PD-L1xCD28 TRACIr (JANX009) and on-track for production and release of drug substance and drug product to support an IND filing.

Evaluations of TROP2-TRACTr to support development candidate selection are ongoing.

We anticipate providing an interim clinical update from the PSMA-TRACTr (JANX007) trial in the second half of 2023, submitting an IND for our EGFR-TRACTr (JANX008) in the second half of 2022, and selecting a development candidate for our TROP2-TRACTr in 2023. In addition, we selected a PD-L1xCD28 TRACIr development candidate in the fourth quarter of 2021 and we expect to submit an IND for this product candidate (JANX009) in 2023.

"We have also made strong additions to our management team and Board of Directors that will be critical as we continue to execute on our development and clinical plans," said Dr. Campbell.

Management team and Board strengthened with key appointments.

Strengthened management team with appointment of Brenda Van Vreeswyk as Head of Human Resources. Brenda brings extensive Human Resources leadership and operations expertise to Janux. Prior to joining Janux, she was Director, HR for Neurocrine Biosciences.

Strengthened Board of Directors with addition of Winston Kung. Winston brings a breadth of operational leadership from both large and small therapeutics companies, as well as a track record of deal-making and financial acumen to Janux’s Board. Winston is currently the Chief Financial Officer and Chief Operating Officer at PMV Pharma.

Janux is also participating in a fireside chat at Cowen’s 6th Annual IO Next Summit on Friday, November 11. A live webcast of the presentation may be accessed via the Investors & Media section of Janux’s website. An archived replay of the webcast will be available on the website for approximately 90 days following the presentation.

THIRD QUARTER 2022 FINANCIAL HIGHLIGHTS:

Cash and cash equivalents and short-term investments: As of September 30, 2022, Janux reported cash and cash equivalents and short-term investments of $338.8 million, compared to $375.0 million at December 31, 2021.

Research and development expenses: Research and development expenses for the quarter ended September 30, 2022, were $13.7 million, compared to $8.4 million for the comparable period in 2021.

General and administrative expenses: General and administrative expenses for the quarter ended September 30, 2022, were $6.1 million, compared to $3.7 million for the comparable period in 2021.

Net loss: For the quarter ended September 30, 2022, Janux reported a net loss of $16.7 million, compared to a net loss of $10.8 million for the comparable period in 2021.

On November 10, 2022 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, reported business updates and financial results for the third quarter ended September 30, 2022 (Press release, Poseida Therapeutics, NOV 10, 2022, View Source [SID1234623720]).

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"Throughout the quarter we have advanced our wholly-owned and partnered portfolios of cell and gene therapies for patients with cancer and rare diseases. Despite macro-economic and market challenges facing our industry, we continue to focus on executing on our top priorities," said Mark Gergen, Chief Executive Officer of Poseida. "We are excited about our collaborations with Takeda and Roche, which have already begun to deliver as we achieved our first clinical milestone under the Roche collaboration. In addition, we are advancing our fully allogeneic CAR-T portfolio and look forward to sharing initial data from both the BCMA and MUC1-C programs soon. While we remain encouraged by the results in our autologous P-PSMA-101 program, we have stopped enrollment in the Phase 1 trial and deprioritized this program as we believe that our allogeneic platform is the key to unlocking the promise of cell therapies."

Program Updates

CAR-T Programs

In cell therapy, the Company is focused on two allogeneic CAR-T programs progressing in Phase 1 clinical trials:

MUC1-C Program

P-MUC1C-ALLO1 is an allogeneic CAR-T product candidate targeting solid tumors derived from epithelial cells, including breast and ovarian cancers. Poseida is currently evaluating P-MUC1C-ALLO1 in a Phase 1 clinical trial and plans to share an initial early clinical data update on the program at the European Society for Medical Oncology Immuno-Oncology (ESMO I-O) 2022 Annual Congress, which is taking place in Geneva, Switzerland and online in December 2022.

BCMA Program

P-BCMA-ALLO1 is an allogeneic CAR-T product candidate targeting relapsed refractory multiple myeloma partnered with Roche. Poseida is currently evaluating P-BCMA-ALLO1 in a Phase 1

clinical trial and plans to share an initial early clinical data update on the program at ESMO (Free ESMO Whitepaper) I-O, which is taking place in Geneva, Switzerland and online in December 2022.

Autologous PSMA Program

P-PSMA-101 is a solid tumor autologous CAR-T product candidate targeting prostate-specific membrane antigen, or PSMA, being developed to treat patients with metastatic castrate-resistant prostate cancer and salivary gland carcinoma. The Company has been evaluating P-PSMA-101 in a Phase 1 trial, however, has made the strategic decision to stop further enrollment. The clinical data from the Phase 1 trial is still being collected and analyzed and will be utilized to inform other solid tumor allogeneic programs, including the Company’s preclinical allogeneic program, P-PSMA-ALLO1.

Gene Therapy Programs

In gene therapy, the Company is advancing multiple gene therapy programs in liver-directed diseases:

OTC Program

P-OTC-101 is an in vivo program for the treatment of urea cycle disease caused by congenital mutations in the ornithine transcarbamylase (OTC) gene. The Company is developing the P-OTC-101 program utilizing a hybrid delivery system and working on an updated timeline for the program.

FVIII Program

The Company is advancing its P-FVIII-101 program partnered with Takeda, which is in development for the in vivo treatment of Hemophilia A. P-FVIII-101 utilizes piggyBac gene modification delivered via lipid nanoparticle that has demonstrated stable and sustained Factor VIII expression in animal models. The Company plans to present preclinical data from this program at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition being held in New Orleans and online in December 2022.

Financial Results for the Third Quarter 2022

Revenues

Revenues were $116.3 million for the three months ended September 30, 2022, and $120.4 million for the nine months ended September 30, 2022, consisting of revenue earned from the collaboration and license agreement with Takeda that the Company entered into in the fourth quarter of 2021 and the Roche Collaboration Agreement which became effective in the third quarter of 2022, compared to no revenues for the same periods in 2021.

Research and Development Expenses

Research and development expenses were $35.1 million for the three months ended September 30, 2022, compared to $32.5 million for the same period in 2021. The increase was primarily due to an increase in personnel expenses as a result of increased headcount, which included an increase in stock-based compensation expense, offset by the wind-down of the Company’s P-BCMA-101 autologous program as the Company transitions to the allogeneic program.

For the nine months ended September 30, 2022, research and development expenses were $119.0 million, compared to $97.6 million for the same period in 2021. The increase was primarily due to an increase in personnel expenses as a result of increased headcount, which included an increase in stock-based compensation expense and an increase in overall active clinical programs offset by the

wind-down of the Company’s P-BCMA-101 autologous program as the Company transitions to the allogeneic program.

General and Administrative Expenses

General and administrative expenses for the three months ended September 30, 2022 and 2021, were $9.4 million and $9.1 million, respectively. For the nine months ended September 30, 2022 and 2021, general and administrative expenses were $28.2 million and $26.3 million, respectively. The increases were primarily related to an increase in personnel expenses due to an increase in headcount, which included an increase in stock-based compensation expense.

Net Income (Loss)

Net income was $70.4 million and net loss was $30.7 million for the three and nine months ended September 30, 2022, respectively, compared to net loss of $42.4 million and $126.4 million for the three and nine months ended September 30, 2021, respectively.

Financing and Cash Position

In August 2022, Poseida announced the closing of an underwritten public offering of 23,000,000 shares of its common stock for total net proceeds of $75.3 million.

In the third quarter, the Company announced the Roche collaboration, which included a $110.0 million upfront payment and $110.0 million of expected near term milestones. In Q3 2022, the Company earned the first of those milestones, totaling $35.0 million, which is classified in accounts receivable as of September 30, 2022.

As of September 30, 2022, the Company’s cash, cash equivalents and short-term investments balance was $279.0 million excluding the $35 million milestone that was earned and not yet received as of September 30, 2022. Poseida expects that its cash, cash equivalents and short-term investments together with the remaining near-term milestones and other payments from Roche will be sufficient to fund operations into at least mid-2024.