On November 8, 2022 MannKind Corporation (Nasdaq: MNKD) reported financial results for the third quarter and nine months ended September 30, 2022 (Press release, Mannkind, NOV 8, 2022, View Source [SID1234623369]).

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"In the third quarter, we grew total revenues by 48% over 2021 as our collaboration with United Therapeutics had its first full quarter during which we recognized both manufacturing revenue and royalties associated with the launch of Tyvaso DPI," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "In addition, our Endocrine Business Unit grew revenues 67% over 2021 as we integrated the V-Go acquisition and continued to grow Afrezza demand."

Third Quarter 2022 Results

Total revenues were $32.8 million for the third quarter of 2022, reflecting Afrezza net revenue of $10.8 million, V-Go net revenue of $5.4 million, collaborations and services revenue of $10.3 million, and royalties of $6.2 million. Afrezza net revenue increased 11% compared to $9.8 million in the third quarter of 2021 as a result of price (including a more favorable gross-to-net adjustment) and higher patient demand, partially offset by wholesaler inventory ordering patterns which resulted in lower inventory levels for the third quarter of 2022. Collaborations and services revenue decreased $2.1 million compared to the third quarter of 2021 primarily due to the completion of the research and development ("R&D") services associated with our collaboration with United Therapeutics ("UT"), which was mostly offset by manufacturing revenue from sales of Tyvaso DPI to UT following the launch of Tyvaso DPI in June 2022.

Afrezza gross profit for the third quarter of 2022 was $8.7 million compared to $5.9 million in the same period of 2021, an increase of $2.8 million, or 47%, which was driven by an increase in Afrezza sales and a decrease in cost of goods sold. Afrezza’s cost of goods sold decreased by $1.7 million, or 45%, compared to the same period in 2021, primarily due to a $2.0 million decrease in excess capacity costs. Afrezza gross margin in the third quarter of 2022 was 81% compared to 61% for the same period in 2021. V-Go gross profit for the third quarter of 2022 was $2.5 million with a gross margin of 46%.

Cost of revenue – collaborations and services in the third quarter of 2022 was $12.4 million compared to $6.1 million for the same period in 2021, an increase of $6.4 million, primarily due to an increase in manufacturing activities for the production of Tyvaso DPI.

R&D expenses for the third quarter of 2022 were $4.1 million compared to $3.6 million for the third quarter of 2021. This $0.5 million increase was mainly related to personnel costs for headcount hired in the second half of 2021, partially offset by a decrease in the Afrezza pediatrics clinical study (INHALE-1) due to study startup costs incurred in the third quarter of 2021.

Selling, general and administrative ("SG&A") expenses for the third quarter of 2022 were $22.6 million compared to $17.2 million for the third quarter of 2021. This $5.4 million increase was primarily attributable to V-Go promotional efforts, the elimination of a co-promotion collaboration (which permitted some expenses associated with the sales force to be recognized as cost of revenue for collaborations and services in the third quarter of 2021), higher stock-based compensation, the net impact of personnel-related costs due to Afrezza sales force restructuring and increased professional fees.

For the third quarter of 2022, the gain on foreign currency translation (for insulin purchase commitments denominated in Euros) was $1.8 million compared to $2.1 million for the third quarter of 2021. The fluctuation was due to a change in the U.S. dollar to Euro foreign currency exchange rate.

Interest income, consisting of interest on investments net of amortization, increased $0.6 million for the third quarter of 2022 to $0.7 million primarily due to higher yields on our marketable securities and money market funds.

Interest expense on the financing liability was $2.5 million for the third quarter of 2022, representing interest incurred on the November 2021 sale and lease-back of our manufacturing facility in Danbury, CT.

The net loss for the third quarter of 2022 was $14.4 million, or $0.06 per share, compared to $4.4 million in the third quarter of 2021, or $0.02 per share. The $10.0 million increase in net loss was primarily due to an increase in selling, general and administrative expense, interest on the financing liability, and the $4.9 million gain on extinguishment of debt in the third quarter of 2021.

Nine Months September 30, 2022

Total revenues were $63.7 million for the nine months ended September 30, 2022, reflecting Afrezza net revenue of $31.3 million, V-Go net revenue of $7.5 million, collaborations and services revenue of $18.4 million and royalties of $6.5 million. Afrezza net revenue increased 13% compared to $27.8 million in the nine months ended September 30, 2021 as a result of price (including a more favorable gross-to-net adjustment) higher product demand and a more favorable cartridge mix. Collaborations and services revenue for the nine months ended September 30, 2022 decreased $16.7 million compared to the same period in the prior year, primarily due to the completion of the R&D services associated with our collaboration with UT, which was partially offset by revenues associated with Tyvaso DPI of $15.8 million. As of September 30, 2022, $32.2 million of revenue associated with UT remains deferred and will be recognized as commercial product is sold to UT.

Afrezza gross profit for the nine months ended September 30, 2022 was $23.6 million, compared to $15.3 million in the same period of 2021, an increase of $8.3 million, or 54%, which was driven by an increase in Afrezza sales and a decrease in cost of goods sold. Afrezza’s cost of goods sold for the nine months ended September 30, 2022 decreased by $4.8 million, or 38%, compared to the same period in 2021, primarily due to a $3.8 million decrease in excess capacity costs and a $2.0 million fee incurred for the amendment of the Insulin Supply Agreement in the prior year period. Afrezza gross margin for the nine months ended September 30, 2022 was 75% compared to 55% for the same period in 2021. V-Go gross profit for the nine months ended September 30, 2022 was $3.3 million with a gross margin of 44%.

Cost of revenue – collaborations and services for the nine months ended September 30, 2022 was $29.5 million compared to $14.9 million for the same period in 2021, an increase of $14.6 million, primarily due to an increase in manufacturing activities for the production of Tyvaso DPI.

R&D expenses for the nine months ended September 30, 2022 were $12.6 million compared to $8.4 million for the same period in 2021. This $4.2 million increase was primarily attributable to personnel costs for headcount hired in the second half of 2021, development activities on our product pipeline, and the Afrezza pediatrics clinical study (INHALE-1).

SG&A expenses for the nine months ended September 30, 2022 were $69.4 million compared to $54.7 million for the same period in 2021. This $14.7 million increase was primarily attributable to a pilot promotional effort aimed at primary care physicians that began in Q4 2021, elimination of a co-promotion collaboration (which permitted some expenses associated with the sales force to be recognized as cost of revenue from collaborations and services in the same period of 2021), promotional expenses to support V-Go, higher stock-based compensation and increased professional and consulting fees.

For the nine months ended September 30, 2022, the gain on foreign currency translation (for insulin purchase commitments denominated in Euros) was $8.3 million compared to $5.0 million for the same period of 2021. The fluctuation was due to a change in the U.S. dollar to Euro foreign currency exchange rate.

Interest income, consisting of interest on investments net of amortization, increased $1.5 million for the nine months ended September 30, 2022 to $1.6 million primarily due to higher yields on our marketable securities and money market funds.

Interest expense on the financing liability was $7.3 million for the nine months ended September 30, 2022, representing interest incurred on the November 2021 sale and lease-back of our manufacturing facility in Danbury, CT.

The net loss for the nine months ended September 30, 2022 was $69.5 million, or $0.27 per share, compared to $52.9 million in the same period of 2021, or $0.21 per share. The $16.6 million increase in the net loss was primarily due to higher cost of revenue for collaborations and services due to increased manufacturing activities for Tyvaso DPI, higher selling, general and administrative expenses, interest on the financing liability and increased research and development expenses, offset by a $17.2 million loss on the extinguishment of debt in 2021.

As of September 30, 2022, cash and cash equivalents and investments were $177.8 million.

Conference Call

MannKind will host a conference call and presentation webcast to discuss these results today at 9:00 a.m. Eastern Time. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at mannkindcorp.com under Events & Presentations. A replay will be available on MannKind’s website for 14 days.

On November 8, 2022 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported business highlights and financial results for the third quarter ended September 30, 2022 (Press release, Delcath Systems, NOV 8, 2022, View Source [SID1234623368]).

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Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. (PRNewsfoto/Delcath Systems, Inc.)

Recent Business Highlights

During and since the third quarter, Delcath:

Confirmed the pending resubmission of the NDA for the Hepzato Kit (melphalan hydrochloride for injection/Hepatic Delivery System) to the FDA by the end of the year,

Attracted a growing number of sites to our Expanded Access Program (EAP),

Strengthened its balance sheet by raising $5 million in a private placement priced at market,

Reached terms of settlement to end its dispute with medac, its former distributor in Europe, and

Announced that independent investigators published Predictive Parameters in Patients Undergoing Percutaneous Hepatic Perfusion with Melphalan for Unresectable Liver Metastases from Uveal Melanoma: A Retrospective Pooled Analysis in the journal Cardiovascular and Interventional Radiology
"We are excited by the level of clinician interest in Hepzato and have enrolled three EAP sites with an additional four sites in process" said Gerard Michel, Chief Executive Officer of Delcath. Mr. Michel added, "We continue to make progress toward the resubmission of the Hepzato Kit NDA by the end of this year, and assuming a six-month review, we consequently would expect a PDUFA date by the end of June 2023."

Third Quarter 2022 Results

Income Statement Highlights.

Total revenue for the three months ended September 30, 2022, was approximately $0.9 million, compared to $0.5 million for the prior year period, from our sales of CHEMOSAT in Europe. This increase in product revenue is primarily due to direct product sales for the third quarter of 2022 compared to the revenue share arrangement with our distribution partner in Europe during the third quarter of 2021.

Research and development expenses for the quarter were $4.0 million, compared to $3.0 million in the prior year quarter. The growth in R&D expense is primarily due to increased activity related to the expenses incurred in preparation for our NDA filing by the end of the year. Selling, general and administrative expenses for the quarter were approximately $4.5 million, compared to $4.0 million in the prior year quarter. The increase in general and administrative expenses was primarily due to the settlement of the medac litigation offset by lower share-based compensation expense.

The Company recorded a net loss for the three months ended September 30, 2022 of $8.5 million, $0.92 per share (basic and diluted), compared to a net loss of $7.1 million, $0.94 per share (basic and diluted), for the same period in 2021.

Balance Sheet Highlights

On September 30, 2022, the Company had cash, cash equivalents and restricted cash totaling $14.0 million, as compared to cash, cash equivalents and restricted cash totaling $27.0 million on December 31, 2021. During the three months ended September 30, 2022, and September 30, 2021, we used $5.2 million and $4.9 million, respectively, of cash in our operating activities.

On July 20, 2022, we closed a private placement for the issuance and sale of 690,954 shares of common stock and 566,751 pre-funded warrants to purchase Common Stock (the "Pre-Funded Warrants") to certain investors. Each share of common stock was sold at a price per share of $3.98 and the Pre-Funded Warrants were sold at a price of $3.97 per Pre-Funded Warrant. The Pre-Funded Warrants have an exercise price of $0.01 per share of common stock and are immediately exercisable. We received gross proceeds from the Private Placement of approximately $5.0 million before deducting offering expenses.

On November 8, 2022 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that Shanghai Henlius Biotech, Inc. has received investigational new drug (IND) approval from China’s National Medical Products Administration (NMPA) for a Phase 2 clinical trial of AC101 (HLX22), a monoclonal HER2 antibody, in combination with anti-PD-1 monoclonal antibody HANSIZHUANG (serplulimab), HANQUYOU (trastuzumab) and chemotherapy as a 1st line treatment for HER2-positive locally advanced/metastatic gastric cancer patients (Press release, Alligator Bioscience, NOV 8, 2022, View Source [SID1234623365]).

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Alligator out-licensed AC101 (HLX22) to the South Korean company AbClon, Inc. in 2016, who sub-licensed the drug candidate to Henlius Biotech for clinical and commercial development in China. Alligator retains an ownership interest entitling the company to 35% of AbClon’s income from the agreement with Henlius.
In September 2022, Henlius announced the completion of the Phase 1 trial of AC101 (HLX22) in patients with HER2 overexpressing advanced solid tumors, in which it demonstrated a good safety and tolerability profile.

"Henlius is making very encouraging progress in its clinical development of AC101 (HLX22) in gastric cancer," said Søren Bregenholt, CEO of Alligator Bioscience. "Following the good safety and tolerability results from the Phase 1 study in September, this is now the second Phase 2 study the company has initiated with this candidate in this indication. It is a further boost to the potential of our AC101 (HLX22) asset, and we are particularly looking forward to seeing what results this new combination setting yields, especially as it includes the addition of the anti-PD-1 monoclonal antibody serplulimab."

Henlius initiated a prior Phase 2 clinical trial to evaluate AC101 (HLX22) in combination with HANQUYOU (trastuzumab) and chemotherapy as a first-line treatment for HER2-positive locally advanced/metastatic gastric cancer patients in September 2021. The estimated primary completion date is April 2023, and the study completion date is expected in September 2024.

The information was submitted for publication, through the agency of the contact persons set out below, at 9.30 a.m. CET on November 8, 2022.

On November 8, 2022 Perrigo Company plc (NYSE: PRGO) ("Perrigo" or the "Company"), a leading provider of Consumer Self-Care Products, reported financial results for the third quarter ended October 1, 2022 (Press release, Perrigo Company, NOV 8, 2022, View Source [SID1234623342]). All comparisons are against the prior year fiscal third quarter, unless otherwise noted.

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President and CEO, Murray S. Kessler commented, "Perrigo third quarter results were strong. Net sales, adjusted gross margin, adjusted operating income and adjusted diluted EPS grew substantially compared to prior year in the face of continued macro-economic headwinds. We gained market share globally, including increases across every segment as store brands continued to gain share from national brands. Although revenue growth in the quarter was robust, it was below our estimates due to unfavorable currency translation, labor shortages effecting supply and slower category growth rates."

Kessler continued, "Importantly, business fundamentals are strong, the labor issue has improved and we just announced the first major step in our Supply Chain Reinvention Program through the infant formula investment. These, along with other margin enhancement programs being implemented, including further strategic pricing initiatives, will enable Perrigo to deliver outsized growth in 2023."

Kessler concluded, "Going forward, our focus is on execution. Successful integration of HRA, achievement of HRA synergies, integration of the Gateway plant, implementation of supply chain initiatives and reducing leverage as planned will position Perrigo to achieve strong top and bottom line growth for years to come."

Refer to Tables I – VI at the end of this press release for a reconciliation of non-GAAP adjustments to the current year and prior year periods and additional non-GAAP information. The Company’s reported results are included in the attached Consolidated Statements of Operations, Balance Sheets and Statements of Cash Flows.

Third Quarter 2022 Perrigo Results from Continuing Operations

Third Quarter 2022 Net Sales Change Compared to Prior Year

Reported

Net Sales

Net Acquisitions
& Divestitures
Adjustment

Foreign

Exchange
Adjustment

Organic

Net Sales

CSCA

4.0 %

3.3 %

— %

7.3 %

CSCI

8.4 %

(20.3) %

20.2 %

8.3 %

Total Perrigo

5.5 %

(4.5) %

6.7 %

7.7 %

Reported net sales increased 5.5%, constant currency net sales increased 12.3% and organic net sales increased 7.7%. Reported net sales were driven by 1) $81 million in constant currency net sales from the acquisition of HRA, 2) $55 million in strategic pricing actions across both Consumer Self-Care segments, 3) U.S. store brand share gains versus national brands and store brand competitors, and growing share in the E.U. marketplace, and 4) an increase of $25 million in cough/cold-related product sales3 that primarily benefited the Upper Respiratory category. These drivers also benefited from e-commerce growth and new product sales. This growth was partially offset by 1) the impact of unfavorable currency translation of $70 million, 2) $31 million from the divested Latin American businesses and ScarAway brand, and 3) lower net sales in certain categories, particularly in the CSCI Healthy Lifestyles category.

Third quarter reported operating income was $33 million, compared to operating income of $438 million in the prior year period. This decrease was due primarily to $418 million related to the Omega arbitration award received in the prior year. Adjusted operating income grew $21 million, or 19.2%, to $133 million. Constant currency adjusted operating income increased 32.2% driven by 1) higher gross profit flow-through resulting from strategic price increases, higher sales volumes and the addition of HRA, and 2) the absence of two product recalls that occurred in the prior year. These increases were partially offset by 1) a $36 million impact from inflation, including higher freight & distribution expenses, 2) higher operating expenses, driven primarily by the addition of HRA, and 3) divested businesses.

Reported net loss was $52 million, or ($0.39) per diluted share, compared to reported net loss of $54 million, or ($0.40) per diluted share, in the prior year period. Excluding certain charges as outlined in Table I, third quarter 2022 adjusted net income was $76 million, or $0.56 per diluted share, compared to $61 million, or $0.45 per diluted share, in the prior year. Constant currency EPS for the quarter was $0.65.

(3)

Cough/cold-related net sales includes the cough/cold sub-category within Upper Respiratory and the Pain and Sleep Aids category.

Third Quarter 2022 Business Segment Results from Continuing Operations

Consumer Self-Care Americas Segment

Third Quarter 2022 Net Sales Change Compared to Prior Year

Reported

Net Sales

Net Acquisitions
& Divestitures
Adjustment

Foreign

Exchange
Adjustment

Organic

Net Sales

CSCA

4.0 %

3.3 %

— %

7.3 %

CSCA reported net sales of $722 million increased 4.0%, and organic net sales increased 7.3%. Net sales growth was driven by strategic price increases, U.S. store brand share gains versus national brands and store brand competitors, and new product launches. Primary category drivers are provided below.

Upper Respiratory
Net sales of $132 million increased 8.4% due primarily to share gains from national brands and store brand competitors in cough/cold and allergy, and the new launch of Nasonex24HR. This growth was partially offset by an unfavorable 4.8 percentage points from the divested Latin American businesses.

Nutrition
Net sales of $124 million increased 18.1% due primarily to store brand share gains in infant formula, due in part to a national brand recall, as well as third-party contract sales. Oral electrolytes also contributed positively to sales in the quarter.

Digestive Health
Net sales of $120 million increased 8.1% due primarily to increased manufacturing capacity and demand for Polyethylene Glycol 3350, and new products, including Omeprazole Cool Mint. Growth in the category was partially offset by an unfavorable 2.2 percentage points from the divested Latin American businesses.

Pain & Sleep-Aids
Net sales of $104 million decreased 4.1% due primarily to the unfavorable impact of 7.7 percentage points from the divested Latin American businesses, partially offset by higher demand for children’s analgesics products.

Oral Care
Net sales of $84 million increased 9.0% due primarily to Plackers and REACH, in addition to growth in store brand offerings, primarily manual toothbrushes.

Healthy Lifestyle
Net sales of $74 million increased 2.4% due primarily to increased distribution of store brand smoking cessation products, partially offset by the discontinuation of diabetes products.

Skin Care
Net sales of $49 million increased 5.4% due primarily to the addition of HRA brands, including Mederma and Compeed, partially offset by the unfavorable impact of 3.0 percentage points from the divested Latin American businesses and ScarAway brand, and discontinued products.

Women’s Health
Net sales of $12 million increased 19.2% due primarily to the addition of HRA brands, including ella.

Vitamins, Minerals, and Supplements ("VMS") and Other
Net sales of $23 million decreased 44.8% due primarily to the unfavorable impact of 17.0 percentage points from the divested Latin American businesses.

Reported operating income was $75 million compared to operating income of $90 million in the prior year quarter. Adjusted operating income decreased $1 million to $104 million due primarily to 1) a $31 million impact from inflation, including higher freight & distribution expenses, 2) higher operating expenses primarily related to the inclusion of HRA, 3) lower profitability of contract sales to the divested Rx business, and 4) the impact of divested businesses. These factors were offset by higher gross profit flow-through resulting from net sales growth and the addition of HRA.

Consumer Self-Care International Segment

Third Quarter 2022 Net Sales Change Compared to Prior Year

Reported

Net Sales

Net Acquisitions
& Divestitures
Adjustment

Foreign

Exchange
Adjustment

Organic

Net Sales

CSCI

8.4 %

(20.3) %

20.2 %

8.3 %

CSCI reported net sales increased 8.4%, constant currency net sales increased 28.6% and organic net sales increased 8.3%. Organic net sales growth was driven by strategic price increases and higher sales volumes led by new product launches. Primary category drivers are provided below.

Skin Care
Net sales of $132 million increased 15.9%, or 37.2% excluding the impact of currency, driven primarily by the addition of HRA brands, including Compeed, strategically priced new products in the Sebamed and ACO skincare lines, and higher net sales of anti-parasite offerings that are outpacing strong category growth.

Upper Respiratory
Net sales of $63 million increased 20.8%, or 43.8% excluding the impact of currency, led by strong demand for cough/cold products, including Bronchostop, Bronchonolo, Coldrex and U.K. store brands.

VMS
Net sales of $46 million decreased 15.9%, or 0.2% excluding the impact of currency, due primarily to lower overall category consumption and lower sales of the nutraceutical products including Granufink and Zaffranax were mostly offset by the restocking of the Abtei brand in Germany following the third quarter 2021 recall of certain batches.

Women’s Health
Net sales of $30 million increased 123.1%, or 163.4% excluding the impact of currency, due primarily to the addition of HRA brands, including ellaOne and NorLevo.

Pain & Sleep-Aids
Net sales of $29 million decreased 13.9%, or an increase of 2.4% excluding the impact of currency, due primarily to higher demand for Solpadeine, a paracetamol-based analgesics product.

Healthy Lifestyle
Net sales of $25 million decreased 32.6%, or 19.9% excluding the impact of currency, due primarily to lower category consumption in weight management and smoking cessation, impacting XLS Medical and NiQuitin, respectively.

Digestive Health, Oral Care and Other
Net sales of $53 million increased 21.5%, or 44.2% excluding the impact of currency, due primarily to the addition of the HRA Rare Diseases portfolio in the Other category.

Reported operating income was $1 million for the quarter compared to $4 million in the prior year. Adjusted operating income increased $17 million, or 36.5%, to $62 million. Constant currency adjusted operating income grew 66.8%, driven by 1) higher gross profit flow-through resulting from higher net sales growth and the addition of HRA, and 2) improved manufacturing productivity. This growth was partially offset by inflation and higher operating expenses, primarily driven by the inclusion of HRA.

Fiscal 2022 Outlook

The Company reiterates its fiscal 2022 organic net sales growth range outlook of 9.0%-10.0% versus the prior year. The Company also reiterates its fiscal 2022 total net sales growth range outlook of 8.5%-9.5%, as expected accretion from the Gateway plant, along with the U.S. and Canadian rights to the Good Start infant formula brand, are expected to offset the worsening impact of currency translation. If foreign currency exchange rates hold near current levels, we now expect net sales in the full year to be unfavorably impacted by 5%-6%.

The Company is updating its fiscal 2022 adjusted EPS range outlook to $2.00-$2.10 from $2.25-$2.35, as solid year-to-date performance in CSCI and accretion from the purchase of the Gateway plant, along with the U.S. and Canadian rights to the Good Start infant formula brand, are expected to be more than offset by lower sales volumes in CSCA, and $0.10 from the worsening impact of currency translation. If foreign currency exchange rates hold near current levels, we now expect adjusted diluted EPS in the full year to be unfavorably impacted by approximately $0.25. The Company now expects to achieve a constant currency adjusted diluted EPS range outlook of $2.25-$2.35.

The Company cannot reconcile its organic net sales growth to reported net sales or its expected adjusted diluted EPS or constant currency adjusted EPS to diluted EPS under "Fiscal 2022 Outlook" without unreasonable effort because certain items that impact net income and other reconciling metrics are out of the Company’s control and/or cannot be reasonably predicted at this time. These items include taxes, interest costs that would occur if the Company issued debt, and costs to acquire and or sell a business if the Company executed such transactions, which could significantly affect our financial results. These items depend on highly variable factors and any such reconciliations would imply a degree of precision that would be confusing or misleading to investors.

On November 8, 2022 Glycotope GmbH, a biotechnology company with a proprietary platform technology for developing antibodies against proteins carrying tumor-specific carbohydrate structures, reported that it will present new data at the 2022 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, being held in Boston, United States, between 8-12 November 2022 (Press release, Glycotope, NOV 8, 2022, View Source [SID1234623341]).

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Patrik Kehler, Chief Scientific Officer of Glycotope GmbH commented: "We are looking forward to providing an update on the progress of our lead antibody program, GT-002, at SITC (Free SITC Whitepaper). The glycosylation-dependent binding of LYPD3 by GT-002 leads to markedly improved tumor-selectivity compared to protein binding antibodies resulting in reduced binding to healthy tissues. In addition, we will deliver a presentation on our GlycoTarget platform, showcasing how, by utilizing the same principle, our technology can be applied to significantly improve selectivity across other targets beside LYPD3."

About GT-002

Antibodies targeting LYPD3 (C4.4A) with increased tumor-specificity. LYPD3 is expressed in various cancer indications with high medical need, including squamous cell carcinoma of the head and neck (HNSCC). Upon binding to LYPD3, the antibody is effectively internalized. The improved tumor-specificity of GT-002 results in reduced binding to healthy-tissue expressed LYPD3 making it suitable for the development of highly potent therapies like ADCs, CARs or radio pharmaceutics.