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Kinnate Biopharma Inc. Announces Third Quarter 2022 Financial Results and Recent Corporate Updates

On November 10, 2022 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a clinical-stage precision oncology company, reported financial results for the quarter ended September 30, 2022, and recent corporate updates (Press release, Kinnate Biopharma, NOV 10, 2022, View Source [SID1234623726]).

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"We continue to make advances with our proprietary programs, and are encouraged by what we’re seeing thus far in the ongoing dose escalation for KIN-2787 monotherapy, our pan-RAF inhibitor," said Nima Farzan, chief executive officer, Kinnate Biopharma Inc. "We are actively investigating multiple targets as part of the Kinnate Discovery Engine and look forward to having a third program enter the clinic next year. We remain well funded to continue to innovate and progress our pipeline of novel small molecule drug candidates."

Pipeline Updates

Announced an update from the ongoing dose escalation for KIN-2787 monotherapy in the global Phase 1 clinical trial, KN-8701. Detailed dose escalation data is expected in the first half of 2023. (View Release)

Subsequent to the KIN-2787 data release, the company anticipates disclosing its next program from the Kinnate Discovery Engine, which is expected to enter the clinic in 2023.

Announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for KIN-2787 for treatment of patients with BRAF Class II or III alteration-positive and/or NRAS mutation-positive stage IIb to IV malignant melanoma that is metastatic or unresectable. (View Release)

Corporate Highlights

Expanded the organization to 86 full-time employees as of September 30, 2022, of which 64 were engaged in research and development activities.

Third Quarter 2022 Financial Results

Cash and Cash Equivalents and Investments Position: As of September 30, 2022, the total of cash and cash equivalents and investments was $262.1 million, excluding cash from its China joint venture, Kinnjiu, and is expected to fund current operations into mid-2024.

Research and Development Expenses: Third quarter research and development expenses for 2022 were $23.5 million, compared to $18.7 million for the same period in 2021.

General and Administrative Expenses: Third quarter general and administrative expenses for 2022 were $7.8 million, compared to $6.1 million for the same period in 2021.

Net Loss: Third quarter net loss for 2022 was $30.7 million, compared to $24.7 million for the same period in 2021.

LianBio Reports Third Quarter 2022 Financial Results and Provides Corporate Update

On November 10, 2022 LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, reported financial results for the third quarter ended September 30, 2022 and provided a corporate update (Press release, LianBio, NOV 10, 2022, View Source [SID1234623725]).

"The LianBio team continues to execute across our clinical development strategies, and we have initiated three pivotal trials of our late-stage, clinically validated programs year-to-date," said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. "We believe the progress we are making across our pipeline ensures we are well-positioned to bring innovative medicines to patients in China, with our first launch anticipated in 2024. We are investing in our team and in our commercial infrastructure, and working closely with patient communities, healthcare professionals and regulators in anticipation of the topline results from our Phase 3 EXPLORER-CN study next year that we expect will support potential registration of mavacamten in China."
Recent Business Highlights and Clinical Development Updates
Following enrollment completion in the Phase 3 EXPLORER-CN trial of mavacamten in Chinese oHCM patients in August 2022, launch and market building initiatives are underway in China
•In August 2022, LianBio submitted a New Drug Application (NDA) to the Department of Health, the Hong Kong Special Administrative Region, China, for mavacamten for the treatment of adults with symptomatic New York Heart Association Class II-III obstructive hypertrophic cardiomyopathy (oHCM). The submission was based on the U.S. Food and Drug Administration approval of mavacamten.
•In September 2022, LianBio collaborated with Beijing Lisheng Cardiovascular Health Foundation to launch Joy from Heart, a hypertrophic cardiomyopathy (HCM) disease awareness campaign in China. Joy from Heart is China’s first disease awareness program dedicated to improving HCM diagnosis rates and supporting HCM education initiatives for patients and healthcare providers.
•In September 2022, mavacamten was added as a Class Ib recommended drug in the 2022 Chinese Guidelines on Hypertrophic Cardiomyopathy published in the Chinese Journal of Heart Failure and Cardiomyopathy.

•LianBio has hired key leadership roles to support the expected mavacamten commercial launch in China, including medical affairs personnel, medical science liaisons, and business unit leaders for key regions.
Phase 3 NANORAY-312 clinical trial of NBTXR3 for the treatment of head and neck cancer initiated in Asia
•In September 2022, LianBio began treating patients in Asia in the global Phase 3 NANORAY-312 trial evaluating NBTXR3 for the treatment of head and neck cancer. LianBio expects this trial to support registration of NBTXR3 in China and other LianBio-licensed territories in Asia.
Phase 3 LIBRA clinical trial of TP-03 for the treatment of Demodex blepharitis initiated in China
•In September 2022, LianBio’s development partner Tarsus submitted an NDA to the U.S. FDA for TP-03 for the treatment of Demodex blepharitis. The submission was based on two pivotal studies of TP-03 demonstrating disease resolution. Tarsus subsequently communicated that the FDA accepted the NDA with a Prescription Drug User Fee Act (PDUFA) target action date of August 25, 2023.
•In November 2022, LianBio announced the initiation of the Phase 3 LIBRA clinical trial of TP-03 in Demodex blepharitis. LianBio expects the LIBRA trial to support registration in China.
Phase 1 clinical trial of BBP-398 SHP2 inhibitor initiated in China
•In November 2022, LianBio announced that it began treating patients with advanced solid tumors in a Phase 1 monotherapy dose escalation trial of BBP-398.
Business is well-positioned to achieve anticipated milestones
•Current cash runway is projected to extend into the second half of 2024.
Key Milestones Anticipated in 2023
Mavacamten
•LianBio expects to report topline data from the Phase 3 EXPLORER-CN trial of mavacamten in Chinese patients with symptomatic oHCM in mid-2023.
TP-03
•LianBio expects to report topline data from the Phase 3 LIBRA trial in the fourth quarter of 2023.
Infigratinib
•LianBio expects to report topline data from the ongoing Phase 2a clinical trial of infigratinib in locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification and other advanced solid tumors with FGFR genomic alterations in the second half of 2023.

BBP-398
•LianBio expects to initiate a Phase 1 clinical trial of BBP-398 in combination with an EGFR-inhibitor in non-small cell lung cancer in the first half of 2023.
Third Quarter 2022 Financial Results
Research & Development Expenses
Research and development expenses were $8.3 million for the third quarter of 2022 compared to $4.7 million for the third quarter of 2021, and $49.2 million for the nine month period ended September 30, 2022 compared to $151.0 million for the nine month period ended September 30, 2021. The decrease was primarily attributable to increased milestone payments in 2021, and was offset by higher development activities to support clinical trials and personnel-related expenses in 2022.
General & Administrative Expenses
General and administrative expenses were $16.3 million for the third quarter of 2022 compared to $8.9 million for the third quarter of 2021, and $46.9 million for the nine month period ended September 30, 2022 compared to $22.5 million for the nine month period ended September 30, 2021. The increase was primarily attributable to increases in payroll and personnel-related expenses (including share-based compensation expense) for increased employee headcount and higher expense for legal, consulting and accounting services.
Net Loss
Net loss was $21.9 million for the third quarter of 2022 compared to net loss of $13.1 million for the third quarter of 2021, and $92.0 million for the nine month period ended September 30, 2022 compared to $175.1 million for the nine month period ended September 30, 2021.
Cash Balance
Cash, cash equivalents, marketable securities and restricted cash at September 30, 2022 totaled $331.8 million compared to $403.2 million as of December 31, 2021. LianBio projects its current cash, cash equivalents, marketable securities, and restricted cash will be sufficient to fund its current operating plan into the second half of 2024.

Bellicum Reports Third Quarter 2022 Financial Results and Provides Operational Update

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]).

"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.

Spectrum Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Corporate Update

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]).

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.

Bolt Biotherapeutics Reports Third Quarter 2022 Financial Results and Provides Business Update

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]).

"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.