Cardinal Health Reports Fourth Quarter and Full Year Results for Fiscal Year 2022

On August 11, 2022 Cardinal Health (NYSE: CAH) today reported fourth quarter fiscal year 2022 revenues of $47.1 billion, an increase of 11% from the fourth quarter of last year (Press release, Cardinal Health, AUG 11, 2022, View Source [SID1234618143]). GAAP operating earnings were $36 million, primarily due to a non-cash, pre-tax goodwill impairment charge of $303 million in the Medical segment. GAAP diluted earnings per share (EPS) were $0.50, primarily due to this impairment, net of tax effects. Non-GAAP operating earnings increased 41% to $450 million, primarily due to the increase in Pharmaceutical segment profit, and non-GAAP diluted EPS increased 36% to $1.05 in the quarter .

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide. (PRNewsfoto/Cardinal Health)

Fiscal year 2022 revenues were $181.4 billion, a 12% increase from fiscal year 2021. GAAP operating loss was $596 million due to non-cash, pre-tax goodwill impairment charges of $2.1 billion in the Medical segment. GAAP diluted loss per share was $3.35, primarily due to these impairments, net of tax effects. Non-GAAP operating earnings decreased 12% to $2.0 billion, primarily due to net inflationary impacts and global supply chain constraints in the Medical segment. Non-GAAP diluted EPS decreased 9% to $5.06 due to the decline in Medical segment profit, partially offset by an increase in Pharmaceutical segment profit, net of tax effects.

"In fiscal year 2022, Medical segment performance was significantly impacted by inflation and supply chain constraints," said Mike Kaufmann, CEO of Cardinal Health. "In addition, the Pharmaceutical segment grew 5% and we generated strong cash flow, returning $1.6 billion to our shareholders through share repurchases and dividends."

Jason Hollar, CFO of Cardinal Health, said, "Looking forward, we have confidence in our Medical Improvement Plan and our long-term targets for growth. We remain committed to the essential role our company plays in healthcare and to delivering value for our customers, employees, and investors."

Fourth-quarter revenue for the Medical segment decreased 11% to $3.8 billion, due to the divestiture of the Cordis business and lower products and distribution volumes.

Medical segment loss of $16 million in the fourth quarter was primarily due to net inflationary impacts and global supply chain constraints in products and distribution. Additionally, the favorable comparison to the prior year PPE inventory reserve was offset by a lower contribution from PPE and the divestiture of the Cordis business.

Long-term financial targets

The company reiterated its long-term targets of low to mid-single digit segment profit growth in the Pharmaceutical segment, mid to high-single digit segment profit growth in the Medical segment, and to average a double-digit combined Non-GAAP EPS growth and dividend yield. Additionally, the company is targeting Medical segment profit of at least $650 million by fiscal year 2025, based on its Medical Improvement Plan.

Leadership changes

The company separately announced that its Board of Directors has elected Jason Hollar, the company’s current Chief Financial Officer, to serve as its next Chief Executive Officer, effective September 1, 2022. Mr. Hollar will succeed Mike Kaufmann, the company’s CEO since January 2018. Mr. Hollar will also join the company’s Board of Directors. Additionally, Patricia English, the company’s current Chief Accounting Officer, will serve as interim CFO, while the company conducts an external search for a permanent CFO.

Recent highlights

Cardinal Health announced that it has acquired the Bendcare group purchasing organization entity, strengthening Specialty Solutions’ Cornerstone RheumatologyTM GPO as a leading rheumatology-focused GPO. The company also made a minority investment in the Bendcare management services organization.
Cardinal Health announced the addition of a new 208,144 square foot distribution center in the Columbus, Ohio, area as part of a multi-year warehouse modernization and growth plan. The new distribution center will support the company’s at-Home Solutions business, a market-leading medical supplies provider and specialized business focused on providing comfortable care in the home for people with chronic and serious health conditions.
Cardinal Health announced the acquisition of ScalaMed, a smart platform that transfers prescriptions directly to patients via a secure mobile app. The acquisition transfers ScalaMed’s technology and assets to Outcomes, a Cardinal Health company.
Cardinal Health hosted its 30th annual Retail Business Conference with more than 4,000 customers in attendance, representing 3,000 unique independent community pharmacies, highlighting the company’s innovations and demonstrating its commitment to customers.
Cardinal Health, along with pharmaceutical distribution peers, reached an agreement with the State of Oklahoma to resolve opioid-related claims. If that and the previously announced agreement with the State of Washington are finalized, 48 of 49 eligible states will be subject to the previously disclosed broad settlement agreement. Additionally, the distributors reached an agreement to settle the opioid-related claims of the majority of West Virginia subdivisions.
Cardinal Health Board of Directors approved a quarterly dividend of $0.4957 per share out of the company’s capital surplus. The dividend will be payable on October 15, 2022 to shareholders of record at the close of business on October 3, 2022.
Upcoming webcasted investor events

Morgan Stanley 20th Annual Global Healthcare Conference at 10:00am EST, September 13, 2022
Webcast

Cardinal Health will host a webcast today at 8:30 a.m. Eastern to discuss fourth quarter and full year results. To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required.

Presentation slides and a webcast replay will be available until August 10, 2023.

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

On August 11, 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 June 30, 2022 and provided a business update (Press release, Phio Pharmaceuticals, AUG 11, 2022, View Source [SID1234618142]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased to have initiated our first-in-human clinical trial of PH-762, while maintaining our spending in the first half of the year. This clinical trial evaluates the safety, tolerability, pharmacokinetics and checkpoint anti-tumor activity of PH-762 in a neoadjuvant setting in subjects with advanced melanoma. This 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. "We look forward to achieving a number of milestones during the second half of 2022, including the planned initiation of our first clinical trial in ACT with PH-762 in partnership with AgonOx, Inc. This trial will evaluate the safety, tolerability and efficacy of DP TILs treated with PH-762 in subjects with advanced metastatic melanoma. We also continue to generate promising new data for our preclinical programs, both in collaboration with our partners and on our own. We expect to present these new data during several presentations at major conferences in the second half of this year."

Quarter in Review and Recent Corporate Updates

Initiated dosing of subjects and enrollment ongoing in a 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 preclinical data at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting which show silencing BRD4 with PH-894, a self-delivering RNAi INTASYL compound, can be used to improve the characteristics of CAR-T cell products during the activation and expansion phases of the cell manufacturing process.
Presented a trial-in-progress poster describing the study outline of a Phase 1b clinical trial of PH-762, a self-delivering RNAi targeting PD-1, for the treatment of advanced melanoma at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. As there is currently no neoadjuvant standard of care for resectable advanced melanoma patients, neoadjuvant treatment with PH-762 provides an alternative therapeutic option to treat these patients.
Upcoming Pipeline Milestones

Plans to initiate a clinical trial evaluating the use of PH-762 and DP TILs in ACT during the fourth quarter of 2022 in partnership with AgonOx, Inc.
Expects to finalize IND-enabling studies for PH-894 in the second half of 2022.
Expects to report top-line data from the first group of subjects 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 June 30, 2022, the Company had cash of $18.0 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 fourth quarter of 2023.

Research and Development Expenses

Research and development expenses decreased 16% to approximately $1.3 million for the quarter ended June 30, 2022, compared with approximately $1.6 million for the quarter ended June 30, 2021. The decrease in research and development expenses was primarily due to the completion of the preclinical studies with PH-762 required for the Company’s clinical trial as a direct therapeutic and the manufacturing costs of PH-894 in the prior year period offset by an increase in personnel-related expenses as a result of a higher headcount.

General and Administrative Expenses

General and administrative expenses increased 8% to approximately $1.2 million for the quarter ended June 30, 2022, compared with approximately $1.1 million for the quarter ended June 30, 2021. The increase in general and administrative expenses was primarily due to a total net increase in payroll and executive search-related expenses as a result of the departure of the Company’s CEO.

Net Loss

Net loss decreased 6% to approximately $2.5 million, or $0.19 per share, for the quarter ended June 30, 2022, compared with $2.7 million, or $0.20 per share, for the quarter ended June 30, 2021. The decrease in net loss was primarily attributable to the decrease in research and development, which was partially offset by an increase in general and administrative expenses as described above.

For the six months ended June 30, 2022, the Company saw a decrease of 15% in net loss to approximately $5.2 million, or $0.38 per share, compared with approximately $6.1 million, or $0.50 per share, for the six months ended June 30, 2021. The decrease in net loss was primarily attributable to a decrease in research and development expenses driven by the completion of the preclinical studies with PH-762 required for the Company’s clinical trial as a direct therapeutic and the manufacturing costs for PH-762 and PH-894 offset by an increase in personnel-related expenses as a result of a higher headcount and increased third-party professional service fees as the Company prepared for and began its clinical trial with PH-762.

About PH-762

PH-762 activates immune cells to better recognize and kill cancer cells. It does so by reducing the expression of PD-1, a clinically validated target for immunotherapy. PD-1 is expressed by T cells and prevents them from killing cancer cells. When PH-762 reduces PD-1 expression, the "brakes" on the immune system are released and activates the T cells to kill the cancer cells. PH-762 is being developed as a standalone drug therapy with local intratumoral administration to a tumor. In addition, it is also being developed as a critical component of cellular immunotherapy, more specifically to improve tumor cell killing capability of adoptively transferred tumor infiltrating lymphocyte (TIL) therapy.

About PH-894

PH-894 silences the epigenetic protein BRD4, which is an intracellular regulator of gene expression that impacts cell differentiation, and hence, cell function. Like other epigenetic targets, BRD4 is a protein that has been shown to be difficult to target with current drug modalities. Since BRD4 is an intracellular protein, antibody therapies cannot be used and small molecule inhibitors tested to date typically lack the required specificity. PH-894 is being developed as a standalone drug therapy with local intratumoral administration to a tumor. In addition, it is also being developed as a critical component of cellular immunotherapy.

LianBio Reports Second Quarter 2022 Financial Results and Provides Corporate Update

On August 11, 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 second quarter ended June 30, 2022 and provided a corporate update (Press release, LianBio, AUG 11, 2022, View Source [SID1234618141]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In the second quarter, LianBio achieved meaningful milestones that we believe serve as a testament to our strength in navigating the complex regulatory environments in Greater China and Asia," said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. "We continue to grow our organization, bringing on key new team members across clinical, medical affairs, quality and commercial functions. Despite clinical site and agency disruptions due to COVID-19 lockdowns in Shanghai and other cities in China, LianBio continued to execute our key clinical development and regulatory priorities, completing enrollment in the Phase 3 EXPLORER-CN trial of mavacamten and submitting marketing applications for both mavacamten and infigratinib in Asia Pacific territories. We believe the enthusiasm for mavacamten’s potential as a treatment for obstructive hypertrophic cardiomyopathy (oHCM) among both the clinical community and the world’s largest oHCM population is high, and we expect to report topline results from EXPLORER-CN in mid-2023. As we work to complete the EXPLORER-CN study over the coming months to support registration in China, we turn our focus to potential launch and preparations for LianBio’s next phase of evolution as a commercial-stage company. We remain on track to initiate three additional registration-enabling clinical programs in China this year, solidifying our position as a key partner in cross-border drug development. I am continually proud of our global team’s efforts to bring innovative medicines to patients in Asia."

Recent Business Highlights and Clinical Development Updates

Mavacamten progress continues in Asia with enrollment completed in China Phase 3 trial and New Drug Application submitted in Singapore

In May 2022, LianBio submitted an NDA to the Singapore Health Sciences Authority 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 (FDA) approval of mavacamten.
In August 2022, enrollment was completed in the Phase 3 EXPLORER-CN clinical trial of mavacamten in Chinese patients with oHCM.
Infigratinib New Drug Application in 2nd line cholangiocarcinoma submitted in Hong Kong

In July 2022, LianBio submitted an NDA to the Department of Health, the Hong Kong Special Administrative Region, China, for infigratinib for the treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement. The submission was based on the FDA approval of infigratinib.
Development partner ReViral Ltd. acquired by Pfizer Inc.

In June 2022, Pfizer completed its acquisition of LianBio’s development partner ReViral and its respiratory syncytial virus therapeutic candidates, including sisunatovir. LianBio holds development and commercial rights to sisunatovir in mainland China, Hong Kong, Macau and Singapore.
LYR-210 clinical development program refined

LianBio plans to conduct a Phase 3 China standalone trial to support regulatory approval in China, leveraging the results of development partner Lyra’s ongoing Phase 3 trial, which is expected to complete enrollment in mid-2023.
Development partner Tarsus advances TP-03 into clinical trial in second indication

In August 2022, LianBio’s development partner Tarsus initiated a Phase 2a clinical trial of TP-03 in patients with meibomian gland disease (MGD).
Development partner Landos Biopharma reports data from NX-13 program

In August 2022, Landos announced topline results from a Phase 1b clinical trial of NX-13 demonstrating NX-13 was well tolerated. Based on these data, Landos plans to initiate a Phase 2 clinical trial to evaluate the safety, efficacy and optimal dosing of NX-13 in ulcerative colitis patients.
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 2022 and 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 initiate a Phase 3 study in Chinese patients with Demodex blepharitis in the second half of 2022. LianBio expects this study will support registration of TP-03 in China.
NBTXR3

LianBio expects to begin dosing patients in Nanobiotix’s global Phase 3 NANORAY-312 clinical trial of NBTXR3 for the treatment of locally advanced head and neck squamous cell carcinoma in elderly patients ineligible for cisplatin in the second half of 2022. LianBio expects this study will support registration of NBTXR3 in China and other LianBio-licensed territories in Asia.
Infigratinib

Enrollment is ongoing in LianBio’s 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.
LianBio expects to begin dosing Chinese patients in Helsinn’s ongoing global pivotal Phase 3 PROOF-301 clinical trial of infigratinib in first-line cholangiocarcinoma (CCA) patients with FGFR2 gene fusions/translocations in the second half of 2022.
BBP-398

LianBio expects to initiate a Phase 1 monotherapy clinical trial of BBP-398 in advanced solid tumors in the fourth quarter of 2022.
LianBio also 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.
Second Quarter 2022 Financial Results

Research & Development Expenses
Research and development expenses were $28.6 million for the second quarter of 2022 compared to $93.0 million for the second quarter of 2021, and $40.9 million for the six month period ended June 30, 2022 compared to $146.4 million for the six month period ended June 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 $14.6 million for the second quarter of 2022 compared to $6.5 million for the second quarter of 2021, and $30.6 million for the six month period ended June 30, 2022 compared to $13.6 million for the six month period ended June 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 $42.4 million for the second quarter of 2022 compared to net loss of $100.4 million for the second quarter of 2021, and $70.1 million for the six month period ended June 30, 2022 compared to $162.0 million for the six month period ended June 30, 2021.

Cash Balance
Cash, cash equivalents, marketable securities and restricted cash at June 30, 2022 totaled $349.4 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.

Poseida Therapeutics Provides Updates and Financial Results for the Second Quarter of 2022

On August 11, 2022 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, reported business updates and financial results for the second quarter ended June 30, 2022 (Press release, Poseida Therapeutics, AUG 11, 2022, View Source [SID1234618140]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We continue to advance our pipeline in both cell and gene therapy, powered by strategic collaborations that validate our unique genetic engineering platform technologies while giving us access to resources and non-dilutive capital," said Mark Gergen, Chief Executive Officer of Poseida. "In cell therapy, we recently announced a broad partnership with Roche focused on developing allogeneic CAR-T cell therapies in hematologic malignancies, including P-BCMA-ALLO1 in multiple myeloma, while preserving a large opportunity for Poseida within the solid tumor space. We look forward to delivering on future milestones with Roche in cell therapy, with our partner Takeda in liver- and HSC-directed in vivo gene therapy, as well as our internal programs in both cell and gene therapy as we continue to execute on future opportunities for growth."

Business Development Update

Cell Therapy Collaboration with Roche

In August, the Company announced it had entered into a strategic collaboration and license agreement with Roche focused on the research and development of allogeneic CAR-T cell therapies directed to hematologic malignancies utilizing Poseida’s proprietary genetic engineering platforms.

Under the agreement, Roche will receive from Poseida either exclusive rights or options to develop and commercialize a number of allogeneic CAR-T programs in Poseida’s portfolio that are directed to hematologic malignancies, including P-BCMA-ALLO1, an allogeneic CAR-T for the treatment of relapsed/refractory multiple myeloma, or R/R MM, and for which a Phase 1 study is underway, and P-CD19CD20-ALLO1, an allogeneic dual CAR-T for the treatment of B cell malignancies. The Company anticipates an IND filing and initiation of a Phase 1 clinical trial for P-CD19CD20-ALLO1 in the first half of 2023.

Poseida will receive $110.0 million upfront from Roche and could receive up to $110.0 million in near-term fees and milestone and other payments. In addition, subject to Roche exercising its options and contingent on achievement of specified development, regulatory, and net sales milestone events, Poseida is eligible to receive payments potentially up to $6.0 billion in aggregate value, as well as tiered net sales royalties into the low double digits, across the multiple programs.

For a subset of both the Poseida portfolio programs licensed or optioned to Roche and the parties’ future collaboration programs, Poseida will conduct the Phase 1 studies and manufacture clinical materials before transitioning the programs to Roche for further development and commercialization. Roche will be solely responsible for the late-stage clinical development and global commercialization of all products that are subject to the collaboration. The effectiveness of the agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act, or HSR Act.

Program Updates

The Company currently has three ongoing CAR-T programs in the clinic, including two allogeneic CAR-T programs progressing in Phase 1 clinical trials:

BCMA Program

P-BCMA-ALLO1 is an allogeneic CAR-T program targeting R/R MM. The Company is currently evaluating P-BCMA-ALLO1 in a Phase 1 clinical trial and this program is now partnered with Roche. Poseida expects initial clinical data from its Phase 1 clinical trial in the second half of 2022 subject to coordination with its partner, Roche.

MUC1C 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, with an initial clinical data update on the program expected in the second half of 2022.

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, or mCRPC, and the Company has recently added salivary gland carcinoma to its clinical protocol. Poseida is currently evaluating P-PSMA-101 in a Phase 1 clinical trial and presented encouraging preliminary results from its Phase 1 clinical trial of P-PSMA-101 in its first solid tumor indication on February 2022 at ASCO (Free ASCO Whitepaper)-GU. The Company may provide a further clinical update at a scientific meeting or forum, likely in 2023. Poseida also has a second-generation program, P-PSMA-ALLO1, which is an allogeneic program, targeting PSMA utilizing a VH binder, in preclinical development.

Liver-Directed Gene Therapy Programs

Poseida is advancing multiple gene therapy programs in liver-directed diseases, including its wholly-owned P-OTC-101 program for the in vivo treatment of the urea cycle disease caused by congenital mutations in the ornithine transcarbamylase (OTC) gene. The Company has made the decision to develop the P-OTC-101 program utilizing a hybrid delivery system and is working on an updated timeline for the program.

Poseida is also 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.

Other Business and Board Leadership Updates

Underwritten Public Offering

On August 8, 2022, the Company completed the sale of an aggregate of 23,000,000 shares of its common stock in an underwritten public offering, at a price of $3.50 per share, including 3,000,000 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares. The net proceeds to Poseida from the offering were approximately $75.3 million after deducting underwriting discounts and commissions and estimated offering expenses.

George M. Church, Ph.D., to Chair Poseida’s Gene Therapy Scientific Advisory Board

In July 2022, the Company announced that renowned geneticist George M. Church, Ph.D., will serve as chair of the Company’s newly formed Gene Therapy Scientific Advisory Board. In this role, Dr. Church will provide advice and counsel on the research and development efforts that drive the Company’s innovative gene therapies.

Charles M. Baum, M.D., Ph.D., Appointed to Board of Directors

In May 2022, Charles M. Baum, M.D., Ph.D., was appointed to the Company’s Board of Directors. Dr. Baum is currently President, Head of Research and Development, and a member of the Board of Directors at Mirati Therapeutics Inc., a company he founded and where he served as CEO from 2012 to 2021.

Financial Results for the Second Quarter 2022

Revenues

Revenues were $2.7 million for the second quarter ended June 30, 2022, and $4.1 million for the six months ended June 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, compared to no revenue for the same periods in 2021.

Research and Development Expenses

Research and development expenses were $35.0 million for the three months ended June 30, 2022, compared to $36.0 million for the same period in 2021. The decrease was primarily due to the wind-down of the Company’s P-BCMA-101 autologous program as the Company transitions to the allogeneic program, offset by an increase in active clinical programs and personnel costs to support those efforts.

For the six months ended June 30, 2022, research and development expenses were $83.9 million, compared to $65.1 million for the same period in 2021. The increase was primarily due to the contract termination to reduce the Company’s autologous manufacturing footprint, costs related to its clinical stage programs from an increase in the number of ongoing clinical trials, and personnel expenses to support these efforts, offset by the wind-down of the Company’s P-BCMA-101 autologous program.

General and Administrative Expenses

General and administrative expenses for the three months ended June 30, 2022 and 2021, were $9.2 million and $8.9 million, respectively. For the six months ended June 30, 2022 and 2021, general and administrative expenses were $18.8 million and $17.2 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 Loss

Net loss was $43.0 million and $101.1 million for the three and six months ended June 30, 2022, respectively, compared to net loss of $45.7 million and $84.0 million for the three and six months ended June 30, 2021, respectively.

Cash Position

As of June 30, 2022, the Company’s cash, cash equivalents and short-term investments balance was $142.6 million, excluding approximately $75.3 million of the net proceeds from the underwritten public offering that Poseida received in August 2022 and $110.0 million of the upfront payment from Roche that the Company, subject to HSR Act clearance, expects to receive in 2022. Poseida expects that its cash, cash equivalents and short-term investments together with expected upfront and near-term fees and milestones other payments from Roche and proceeds from its recent public offering will be sufficient to fund operations into at least mid-2024.

Athenex, Inc. Announces Pricing of $30 Million Public Offering of Common Stock and Warrants

On August 11, 2022 Athenex, Inc. ("Athenex") (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported the pricing of its underwritten public offering of 35,333,334 shares of its common stock and accompanying warrants to purchase up to 35,333,334 shares of common stock at a combined public offering price of $0.75 per share and accompanying warrant and, in lieu of common stock to certain investors, pre-funded warrants to purchase up to 4,666,666 shares of its common stock and accompanying warrants to purchase up to 4,666,666 shares of common stock at a combined public offering price of $0.749 per share and accompanying warrant (Press release, Athenex, AUG 11, 2022, View Source [SID1234618139]). The pre-funded warrants have an exercise price of $0.001 per share, are exercisable immediately, and will expire five years following the date of issuance. The warrants have an exercise price of $1.00 per share, are exercisable immediately, and will expire five years following the date of issuance. The gross proceeds to Athenex from the offering, before underwriting discounts and commissions and offering expenses, are expected to be approximately $30 million. The offering is expected to close on August 15, 2022, subject to customary closing conditions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Athenex intends to use the net proceeds from the proposed offering to fund ongoing clinical development for its product candidates and for working capital and other general corporate purposes.

SVB Securities is acting as sole book-running manager for the offering.

The offering is being made only by means of a previously filed effective registration statement (including a base prospectus) and a preliminary prospectus supplement. Copies of the final prospectus supplement and accompanying prospectus, when available, may also be obtained from: SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525, ext. 6105, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there by any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.