On November 8, 2022 Vaxart, Inc. (NASDAQ: VXRT) reported for the third quarter of 2022, during which the Company made significant progress on its oral vaccine candidates (Press release, Vaxart, NOV 8, 2022, View Source [SID1234623409]).

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"We are encouraged by the growing body of clinical evidence that supports the transformational potential of Vaxart’s oral pill vaccine platform with positive data from both our leading programs, COVID-19 and norovirus," said Andrei Floroiu, Vaxart’s Chief Executive Officer.

Dr. James Cummings, Vaxart’s Chief Medical Officer, said, "During the third quarter, we announced positive top-line Phase II clinical study results for our Wuhan S-only COVID-19 pill vaccine candidate. These data are very encouraging, showing that Vaxart’s vaccine candidate can trigger both serum and mucosal immunity and can boost responses in those having previously received mRNA vaccines. These results highlight the potential of mucosal immunity through remarkable cross-reactive responses. Our Wuhan vaccine candidate showed equally strong activity towards Omicron, something not seen with injectable vaccines. Additionally, we remain confident in our norovirus program, with encouraging recent data from our trial in elderly adults, which suggests similar activity as seen in younger adults. This is not often expected with vaccines and offers another potential source of differentiation for our oral pill vaccine candidate."

"Norovirus is a significant opportunity for Vaxart – with a $10 billion economic burden of disease in the U.S. alone and no approved vaccine against a disease that disproportionately affects older and pediatric populations. Vaxart has generated compelling clinical data across five norovirus trials. We are eagerly anticipating the upcoming results of our norovirus human challenge study at the end of the first quarter or at the start of the second quarter of 2023. We are increasing our focus on the norovirus program, with two additional clinical trials planned to start in the next six months," Mr. Floroiu added.

Vaxart’s oral vaccine platform has the potential to transform the vaccination paradigm globally, by providing significant advantages compared to injectable vaccines. One of the Company’s vaccine candidates was shown to be as protective as a leading injectable against a pandemic respiratory virus in a human flu challenge study. In addition, data from multiple programs suggest that by triggering mucosal immunity the platform could provide cross-reactivity against variants, reduce viral transmission, offer long duration of protection and offer a more tolerable safety profile.

"These potential advantages are in addition to those offered by the oral pill format, which could allow more people to be vaccinated painlessly, easily and faster all around the world. We are in a position to aggressively pursue our two leading clinical programs and are very excited looking into 2023 at the significant milestones for both programs – the readouts of two human challenge studies for norovirus and COVID-19," Mr. Floroiu concluded.

Recent Business Highlights

COVID-19 Vaccine Developments

In September 2022, Vaxart reported positive top-line data from its Phase II COVID-19 trial supporting broad potential of the Company’s COVID-19 vaccine candidates to tackle the challenges of an evolving virus that continues to overcome the immune protection provided by approved vaccines.
Vaxart is the only company with a mucosal vaccine candidate for COVID-19 that has produced Phase II clinical data that shows it stimulates mucosal immunity.
In July 2022, the Company updated Phase I data showing Vaxart’s Spike/Nucleocapsid (S+N) candidate stimulated SARS-CoV-2-specific IgA antibodies in saliva and nasal samples from human subjects and was cross-reactive to many different coronaviruses that are more divergent than circulating variants of SARS-CoV-2.
Norovirus Vaccine Developments

In June 2022, Vaxart reported positive top-line data about its norovirus vaccine candidate.
The data from Vaxart’s Phase Ib trial in subjects aged 55-80 demonstrated that Vaxart’s oral norovirus vaccine candidate stimulated a robust immune response across all doses, with a dose-dependent production of IgA antibody secreting cells.
Results were consistent with previous studies conducted in younger populations, which is typically not the case, as the immune system often weakens with age, and older people tend to have less robust responses to vaccination than younger people.
No vaccine exists in the United States to treat norovirus, a virus that causes up to 21 million cases, 109,000 hospitalizations and 900 deaths annually in the United States.
Corporate Updates

Bolstered management and Board with three significant additions:
In August, named Ray Stapleton, Ph.D. as Chief Technology Officer.
Dr. Stapleton joins Vaxart from Genocea, where he served as CTO and Executive Vice President, working to develop next generation personalized immunotherapies in the forms of vaccines and cell therapies. His prior experience includes senior manufacturing and technical operations roles at a number of biotech companies after spending 15 years in positions of increasing responsibility in Merck and Company’s manufacturing organization.
Also in August, appointed Elaine J. Heron, Ph.D. and W. Mark Watson to the Company’s Board of Directors.
Dr. Heron currently serves on the boards of BioMarin Pharmaceutical, Inc., Palvella Therapeutics, Inc., Visgenx, Inc., and Watershed Medical, Inc. She also serves as an advisor to Kyto Technology and Life Science, Inc. Dr. Heron has over 35 years of experience in the life science research and biotech development sectors.
Mr. Watson is a Certified Public Accountant with more than 40 years of experience in public accounting and auditing, having spent his entire career from January 1973 to June 2013 at Deloitte Touche Tohmatsu and its predecessor, most recently as Central Florida Marketplace Leader.
Planned Clinical Milestones in the COVID-19 and Norovirus Pipelines

Vaxart continues to make progress on its expected milestones:

Start of Phase II trial of Vaxart’s bivalent norovirus vaccine candidate in Q4 2022 or Q1 2023.
Top-line data from ongoing Phase II norovirus challenge study expected at the end of Q1 2023 or early Q2 2023.
Selection of COVID-19 vaccine construct to be used in the UK human challenge study expected in Q4 2022.
After determining which COVID-19 vaccine candidate to advance, Vaxart anticipates updating its plans for its India trials.
Omicron Human Challenge Trial in the UK starting in 2H 2023 using selected vaccine construct.
Financial Results for the Three Months Ended September 30, 2022

Vaxart ended the third quarter with cash, cash equivalents and available-for-sale debt securities of $114.8 million, compared to $131.5 million as of June 30, 2022. The decrease was primarily due to $14.6 million of cash used in operations.
The Company reported a net loss of $29.3 million for the third quarter of 2022, compared to $17.6 million for the third quarter of 2021. Net loss per share for the third quarter of 2022 was $0.23, compared to a net loss of $0.14 per share in the third quarter of 2021. The increase in net loss was primarily due to a significant increase in research and development costs.
Research and development expenses were $22.5 million for the third quarter of 2022, compared to $12.4 million for the third quarter of 2021. The increase was mainly due to increases in headcount and related costs, and in manufacturing and clinical trial expenses related to our COVID-19 and norovirus vaccine candidates.
General and administrative expenses were $7.0 million for the third quarter of 2022, compared to $5.0 million for the third quarter of 2021. The increase was mainly due to increases in headcount and related costs and in legal and professional costs.
Conference Call
The Vaxart senior management team will host a conference call to discuss the business update and financial results for the third quarter of 2022 today, beginning at 4:30 p.m. ET.

On November 8, 2022 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported operating results for the third quarter ended September 30, 2022 and provided pipeline updates (Press release, AnaptysBio, NOV 8, 2022, View Source [SID1234623408]).

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"We are excited about the potential of our novel immune cell modulator pipeline, including our two checkpoint agonists in clinical-stage development, rosnilimab and ANB032. We believe their mechanisms of action, acting directly on cell types mediating disease pathology, have the potential to treat a broad range of autoimmune and inflammatory disorders" said Daniel Faga, interim president and chief executive officer of AnaptysBio. "We’re well capitalized to execute with over $590 million in cash at the end of Q3 as we move forward in our strategic portfolio review."
Rosnilimab (Anti-PD-1 agonist) Program
•Rosnilimab, our investigational wholly owned anti-PD-1 agonist antibody, is in the ongoing AZURE Phase 2 clinical trial in moderate-to-severe alopecia areata, and we anticipate top-line data in Q1 2023.
ANB032 (Anti-BTLA agonist) Program
•ANB032, our investigational wholly owned anti-BTLA agonist antibody, will be advancing with a U.S. IND submission for an initial Phase 2 clinical trial in Q4 2022.
ANB033 (Anti-CD122 antagonist) Program
•ANB033, our investigational wholly owned anti-CD122 antagonist antibody, targets the common beta subunit shared by the IL-15 and IL-2 receptors. IL-15 signaling mediates the survival and maintenance of tissue resident memory T cells (TRM). The presence of long-lived and persistent TRM have been shown to drive tissue-specific immune-mediated inflammation. We anticipate submitting a U.S. IND in first half of 2024.
Imsidolimab (Anti-IL-36 receptor) Program
•Imsidolimab, our investigational wholly owned anti-IL-36R therapeutic antibody, is in Phase 3 trials in generalized pustular psoriasis (GPP), and we anticipate top-line data from the GEMINI-1 Phase 3 clinical trial in Q4 2023 and plan to outlicense imsidolimab prior to potential FDA approval.
GSK Partnered Programs
•PERLA, a head-to head Phase 2 trial of JEMPERLI (dostarlimab) vs. Keytruda in patients with metastatic non-squamous non-small cell lung cancer met its primary endpoint of objective response rate (ORR) of dostarlimab plus chemotherapy versus pembrolizumab plus chemotherapy as assessed by blinded independent central review per RECIST v1.1.
◦GSK will present full results, including the primary endpoint of ORR and the key secondary endpoint of progression-free survival, at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Annual Congress on Friday, December 9th.
•COSTAR, a Phase 2 trial of dostarlimab plus cobolimab, an anti-TIM-3 antagonist antibody, achieved pre-specified efficacy and safety criteria, and GSK is advancing both arms of the COSTAR Lung clinical trial

from Phase 2 to Phase 3, testing both doublet and triplet combinations of dostarlimab plus chemotherapy, and cobolimab plus dostarlimab plus chemotherapy in advanced non-small cell lung cancer who have progressed on prior anti-PD-(L)1 therapy and chemotherapy.
◦Cobolimab was discovered at AnaptysBio and licensed to TESARO, Inc., (GSK) as part of the same collaboration agreement as dostarlimab.
◦AnaptysBio earned a $5 million milestone from GSK in October 2022 on initiation of the first Phase 3 trial with cobolimab.
•Sold our royalty interest on future global net sales of Zejula to a wholly-owned subsidiary of DRI Healthcare Trust for up to $45 million during Q3.
◦Received an upfront payment of $35 million and are eligible for a further $10 million from DRI upon FDA approval of Zejula for the treatment of endometrial cancer, for which the drug is currently in a fully-enrolled ongoing Phase 3 study, to the extent that such approval occurs on or before December 31, 2025.
Third Quarter Financial Results
•Cash, cash equivalents and investments totaled $590.5 million as of September 30, 2022, compared to $615.2 million as of December 31, 2021, for a decrease of $24.7 million. The decrease relates primarily to cash used for operating activities offset by cash received from the Zejula royalty sale and stock option exercises.
•Collaboration revenue was $1.3 million and $3.5 million for the three and nine months ended September 30, 2022, compared to $20.9 million and $62.2 million for the three months and nine months ended September 30, 2021. The decrease relates primarily to one development milestone achieved for JEMPERLI for the three months ended September 30, 2021, and four development milestones achieved for JEMPERLI for the nine months ended September 30, 2021, and no development milestones achieved during the nine months ended September 30, 2022.
•Research and development expenses were $22.1 million and $65.4 million for the three and nine months ended September 30, 2022, compared to $22.2 million and $71.7 million for the three and nine months ended September 30, 2021. The year-to-date decrease was due primarily to reduced clinical costs and manufacturing costs for the Company’s programs. The R&D non-cash, stock-based compensation expense was $1.5 million and $5.0 million for the three and nine months ended September 30, 2022, as compared to $1.8 million and $4.4 million in the same period in 2021.
•General and administrative expenses were $8.9 million and $27.2 million for the three and nine months ended September 30, 2022, compared to $5.4 million and $16.1 million for the three and nine months ended September 30, 2021. The increase was due primarily to $3.8 million of costs incurred from personnel changes in the first quarter of 2022 and non-cash stock compensation expense. The G&A non-cash, stock-based compensation expense was $4.7 million and $15.7 million for the three and nine months ended September 30, 2022, which includes $3.2 million of the $3.8 million one-time costs described earlier as compared to $2.6 million and $7.0 million in the same period in 2021.
•Net loss was $33.5 million and $102.3 million for the three and nine months ended September 30, 2022, or a net loss per share of $1.18 and $3.64, compared to a net loss of $6.7 million and $25.3 million for the three and nine months ended September 30, 2021, or a net loss per share of $0.24 and $0.92.

On November 8, 2022 Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, reported operating results for the three months ended September 30, 2022 (Press release, Quanterix, NOV 8, 2022, View Source [SID1234623407]).

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Financial Highlights

Revenue of $26.6M for Q3 2022 was flat versus Q3 2021 with the prior year NIH RADx funding excluded, and increased 13% over Q2 2022.
Pro-forma gross margin of 35% for Q3 2022 was up 670 bps over Q2 2022 and down 1470 bps from Q3 2021.
For additional information on the pro-forma financial measures included in this press release, please see "Use of Pro-Forma Financial Measures" and "Reconciliation of GAAP to Pro-Forma" below.

Business Highlights

The Bio-Hermes trial we are participating in is nearing completion. This is a prospective trial in partnership with the Global Alzheimer’s Platform Foundation. This prospective validation trial for pTau-181 will generate data in support of our regulatory filing for FDA clearance of the test, which would be the first of its kind in the market.
Quanterix received funding from Alzheimer’s Drug Discovery Foundation (ADDF) to accelerate Alzheimer’s disease diagnostic plasma test development. This is a collaboration with Amsterdam University Medical Centers (Amsterdam UMC) on four phases of clinical trials to validate Quanterix’s multi-analyte test. We are approximately 50% through Phase 1 and showing promising results for Alzheimer’s detection and differential diagnosis of memory complaints, generating four abstracts and one presentation to date.
Published discoveries enabled through Quanterix’s SimoaÒ technology continue to be strong. The technology was highlighted in a record 159 new publications in the third quarter 2022, bringing total Simoa-specific inclusions to over 2,000.
"Our third quarter results were in line with expectations set last quarter when we launched a significant assay quality remediation program," said Masoud Toloue, President and Chief Executive Officer of Quanterix. "We are pleased with the quarter-over-quarter financial and business progress with both revenue and gross margin growing, the program is on track and proceeding to plan. While demand remains robust, we are managing our volume to ensure we deliver quality products to our customers while we focus our efforts to improve the quality and long-term scalability of our product offerings. Our team’s conviction is resolute and the urgency high as our Simoa technology remains the foundation for unlocking new discoveries and innovations in both research and clinical applications, every day."

Quanterix’s third quarter revenue was flat compared to prior year excluding RADx, with consumable revenue declining as the Company balanced demand with assay quality and process improvement initiatives. This shortfall was offset by strong services revenue driven by the Company’s collaboration agreement with Eli Lilly and Company.

Quanterix’s third quarter pro-forma gross margin of 35% declined 1470 bps from 49.8% in the third quarter of 2021. The decline is due primarily to increased inventory reserves (800 bps), the change in allocation of expenses between operating expense and cost of goods sold (500 bps) previously announced in Q2 of this year and a slight revenue decline. Third quarter pro-forma margin increased 670 bps from the prior quarter driven by expense reductions and product mix shift, which offset increased inventory reserves.

Strategic Business Re-Alignment Progress

In August of 2022, the Company announced a comprehensive restructuring and business re-alignment plan in order to fully realize the potential of its Simoa platforms and continue its leadership role in ultrasensitive translational biomarker detection. As a result of the restructuring and the corresponding impact to Quanterix’s stock price, the Company has incurred the following restructuring and related charges in Q3:

Goodwill impairment—$8.2 million;
Impairment of long-lived assets—$8.7 million;
Restructuring expenses—$3.4 million (mainly related to employee costs); and
Other lease costs—$0.6 million.
In addition, the assay redevelopment program designed to improve its ability to manufacture and deliver high-quality assays at scale is on target and moving forward aligned to the plan announced last quarter.

Conference Call

In conjunction with this announcement, Quanterix Corporation will host a conference call on November 8, 2022 at 4:30 p.m. EST. Individuals interested in listening to the conference call may do so by pre-registering here and obtaining a dial-in number and passcode.

A live webcast will also be available at: View Source You may also access the live webcast by visiting the News & Events page within the Investors section of the Quanterix website at www.quanterix.com. The webcast will be available on the Company’s website for one year following completion of the call.

On November 8., 2022 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company leveraging the power of the mitochondria and the peptides encoded in its genome to develop potential breakthrough therapeutics targeting chronic and age-related diseases, reported its financial results for the third quarter ended September 30, 2022 and highlighted recent corporate progress (Press release, CohBar, NOV 8, 2022, View Source [SID1234623406]).

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"I’m pleased with the team’s performance during the third quarter of 2022 in advancing our top priorities, including improving the formulation of CB5138-3, our product candidate for IPF," stated Dr. Joseph Sarret, Chief Executive Officer. "We continue to operate the company in a prudent financial manner, and we completed a reverse stock split, which was a necessary step to regain compliance with Nasdaq and enable potential access to institutional capital. Looking ahead, we are prioritizing activities that will support the planned clinical development of our IPF program and we look forward to communicating additional progress in the near future."

Recent Updates and Third Quarter 2022 Highlights

Formulation Work for CB5138-3 Ongoing: The company continues to advance CB5138-3, its lead program for IPF, through IND-enabling studies and formulation activities. In the second half of 2023, CohBar plans to submit an Investigational New Drug Application (IND) for CB5138-3 to the U.S. Food and Drug Administration pending a suitable formulation.

Strengthened Board with Appointment of Effie Tozzo, Ph.D: CohBar announced the appointment of Dr. Effie Tozzo as an independent director to the company’s board of directors. Dr. Tozzo brings 26 years of research and development expertise at both established pharmaceutical and innovative biotechnology companies, including extensive experience in mitochondria research.

Executed Reverse Stock Split: CohBar implemented a 1-for-30 reverse stock split effective on September 23, 2022. The company utilized this corporate action to regain compliance with Nasdaq’s $1.00 minimum bid price requirement. The company has since received a letter from Nasdaq confirming that it has achieved compliance with the listing requirements.
Third Quarter 2022 Financial Highlights

Cash, Cash Equivalents and Investments: The company had cash, cash equivalents and investments of $18.3 million as of September 30, 2022, compared to $26.2 million as of December 31, 2021. The cash burn for the quarter ended September 30, 2022 was approximately $1.9 million.

R&D Expenses: Research and development expenses were $1.0 million for the three months ended September 30, 2022, compared to $1.6 million in the prior year quarter. The decrease in research and development expenses was primarily due to lower program costs due to the timing of those expenses.

G&A Expenses: General and administrative expenses were $1.4 million for the three months ended September 30, 2022, compared to $1.8 million in the prior year quarter. The decrease in general and administrative expenses was due to lower stock-based compensation costs.

Net Loss: For the three months ended September 30, 2022, net loss, which included $0.4 million of non-cash expenses, was $2.4 million, or $0.82 per basic and diluted share on a post-split basis. For the three months ended September 30, 2021, net loss, which included $0.7 million of non-cash expenses, was $3.4 million, or $1.61 per basic and diluted share on a post-split basis.
Details for the Conference Call:

A simultaneous webcast of the call will be accessible via the Investors section of the CohBar website at www.cohbar.com.
For individuals participating in the Investor Call or webcast, please call or login to the conference audio approximately 10 minutes prior to its start.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on November 8, 2022, through 11:59 p.m. Eastern Time on November 29, 2022. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 10171343. The audio recording will also be available at www.cohbar.com during the same period.

On November 8, 2022 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") reported its financial and operating results for the third quarter ended September 30, 2022 and provided an update on its recent corporate activities and outlook (Press release, Halozyme, NOV 8, 2022, View Source [SID1234623405]).

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"Our third quarter accomplishments are reflective of the expanded opportunities and capabilities at Halozyme that support an enhanced and extended revenue and earnings growth trajectory. DARZALEX SC and Phesgo have continued to demonstrate strong momentum driving 70% year-over-year royalty revenue growth in the third quarter. Our partners also continued to advance their development pipelines with ENHANZE. Our Wave 3 products represent the most near-term opportunities with the potential to launch between 2023 and 2025. We are excited for argenx’s biologics license application to the FDA for efgartigimod SC with ENHANZE for Myasthenia Gravis as well as Roche’s plans for regulatory submissions for Tecentriq SC in the U.S. and EU," said Dr. Helen Torley, president and chief executive officer of Halozyme. "Our leadership in drug delivery technologies and innovative commercial products have augmented our growth initiatives, diversified our revenue streams and extended revenue durability. We look forward to further strengthening our position as the drug delivery partner of choice for pharmaceutical and biotechnology companies with both ENHANZE and our auto-injectors."

Recent Partner Highlights:

In October 2022, Roche Pharmaceuticals China announced the approval of Herceptin (trastuzumab injection subcutaneous with ENHANZE) in China for the treatment of patients with early-stage and metastatic HER2-positive breast cancer.
In September 2022, Janssen initiated a Phase 3 study of lazertinib and amivantamab with ENHANZE in patients with epidermal growth factor receptor (EGFR)-mutated advanced or metastatic non-small cell lung cancer (PALOMA-3).
In September 2022, argenx announced the submission of a biologics license application ("BLA") to the U.S. Food and Drug Administration ("FDA") for subcutaneous ("SC") efgartigimod for the treatment of adults with generalized myasthenia gravis ("MG"). SC efgartigimod is co-formulated with ENHANZE.
In September 2022, Chugai Pharmaceutical Co., Ltd. (a Member of the Roche Group) announced the submission of a New Drug Application in Japan for fixed-dose subcutaneous combination of pertuzumab and trastuzumab (same monoclonal antibodies as Phesgo in U.S. and EU).
In August 2022, Bristol Myers Squibb ("BMS") initiated a Phase 3 trial to compare the drug levels of nivolumab with ENHANZE administered subcutaneously versus intravenous administration in participants with melanoma following complete resection (CheckMate-6GE).
In August 2022, Roche announced that the Phase III IMscin001 study evaluating a subcutaneous formulation of Tecentriq (atezolizumab) with ENHANZE met its co-primary endpoints. The study showed non-inferior levels of Tecentriq in the blood (pharmacokinetics), when injected subcutaneously, compared with intravenous infusion, in cancer immunotherapy-naïve patients with advanced or metastatic non-small cell lung cancer for whom prior platinum therapy has failed. The safety profile of the SC formulation was consistent with IV Tecentriq. Roche announced that they will submit the data for regulatory approval to health authorities globally, including the FDA, resulting in revenue recognition of $19 million for Halozyme in Q3 2022 for associated milestones.
In July 2022, Takeda announced positive topline results from pivotal Phase 3 trial evaluating HYQVIA (Immunoglobulin infusion 10% (Human) with rHuPH20), for maintenance treatment of chronic inflammatory demyelinating polyradiculoneuropathy ("CIDP").
Recent Corporate Highlights:

In August 2022, we completed the sale of $720 million in aggregate principal amount of 1.00% Convertible Senior Notes due 2028. We used a portion of the net proceeds to facilitate an induced conversion with certain holders of our outstanding 1.25% Convertible Senior Notes due 2024. In connection with the induced conversion, we paid the note holders $77.6 million in cash and issued 1.51 million shares. We also used portions of the net proceeds to repay all of the $250 million term loan facility due 2026.
In August 2022, we entered into an amendment to our revolving credit agreement that increased the size of the facility from $350 million to $575 million.
In the third quarter of 2022, we accelerated $100 million of planned share repurchases from 2023 into 2022, for a total of $200 million planned share repurchases in 2022. In August 2022, we repurchased 2.1 million shares of common stock in open market purchases for $90.2 million at an average price per share of $43.09 and entered into an accelerated share repurchase agreement to repurchase $109.8 million of our common stock, for which we took an initial delivery of 2 million shares.
Third Quarter Financial Highlights:

Revenue for the third quarter was $209 million compared to $115.8 million for the third quarter of 2021. The 80% year-over-year increase was driven by an increase in royalty revenue primarily attributable to subcutaneous DARZALEX (daratumumab), the addition of product sales as a result of the Antares Pharma acquisition and an increase in revenues under collaborative agreements due to milestone recognitions from BMS and Roche. Revenue for the quarter included $99.6 million in royalties, an increase of 70% compared to $58.6 million in the prior year period.
Cost of sales for the third quarter was $47.3 million, compared to $18.6 million for the third quarter of 2021. The year-over-year increase was driven by an increase in product sales as a result of the Antares Pharma acquisition.
Amortization of intangibles expense in the third quarter was $27.2 million, an increase from no expense in the third quarter of 2021 due to the Antares Pharma acquisition, in which we acquired intangible assets that are amortized over a useful life related to the auto injector technology platform, XYOSTED and TLANDO.
Research and development expenses for the third quarter were $16.7 million, compared to $8.5 million for the third quarter of 2021. The increase is primarily due to planned investments in ENHANZE, the Antares Pharma acquisition and increases in compensation expense related to the ongoing combined larger workforce.
Selling, general and administrative expenses for the third quarter were $34.5 million, compared to $13.2 million for the third quarter of 2021. The increase was primarily due to the Antares Pharma acquisition and an increase in compensation expense related to the ongoing combined larger workforce.
Operating Income in the third quarter of 2022 was $83.3 million, compared to operating income of $75.6 million in the third quarter of 2021.
Net Income: On a GAAP basis in the third quarter of 2022, net income was $61.6 million, compared with net income of $216.6 million in the third quarter of 2021, which includes the reversal of substantially all of the valuation allowance recorded against the Company’s deferred tax assets and resulted in the recognition of a non-cash income tax benefit during the quarter of $142.5 million. Non-GAAP net income was $103.3 million in the third quarter of 2022, compared with non-GAAP net income of $80.5 million in the third quarter of 2021.1 The Company notes that 2022 is the first year in which Halozyme is recording income tax expense as part of its income statement.
Earnings per Share: On a GAAP basis in the third quarter of 2022, diluted earnings per share was $0.44, compared with $1.48 in the third quarter of 2021. On a non-GAAP basis diluted earnings per share was $0.74, compared with diluted earnings per share of $0.55 in the third quarter of 2021.1
Cash, cash equivalents and marketable securities were $265.6 million on September 30, 2022, compared to $740.9 million on December 31, 2021.
Financial Outlook for 2022

The Company is reiterating its financial guidance for 2022, which was last provided on August 9, 2022 as a result of the close of the Antares Pharma transaction and strong year-to-date results. For the full year 2022, the Company expects:

Total revenue of $655 million to $685 million, representing growth of 48% to 55% over 2021 total revenue primarily driven by projected revenue contribution from the Antares business of $115 million to $125 million. The Company expects revenue from royalties to increase by approximately 70% over revenue from royalties in 2021, to approximately $350 million to $360 million.
GAAP operating income of $240 million to $265 million, which includes one-time transaction costs of approximately $45 million and amortization of approximately $80 million related to the Antares acquisition. Adjusting for these costs, we expect adjusted operating income of $365 million to $390 million. 1
GAAP net income of $170 million to $195 million and non-GAAP net income of $295 million to $320 million.1 The Company notes that 2022 will be the first full fiscal year in which Halozyme will record income tax expense as part of its income statement.
GAAP diluted earnings per share of $1.20 to $1.35 due to acquisition related costs in 2022.
Non-GAAP diluted earnings per share are expected to be $2.10 to $2.25,1 reflective of the projected accretion from the Antares Pharma acquisition.
The Company’s earnings per share guidance does not consider the impact of potential future share repurchases.

Webcast and Conference Call

Halozyme will host its Quarterly Update Conference Call for the third quarter ended September 30, 2022 today, Tuesday, November 8, 2022 at 4:30 p.m. ET/1:30 p.m. PT. The call will be webcast live through the "Investors" section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit the "Investors" section of www.halozyme.com.