On May 8, 2019 Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, reported financial results for the quarter ended March 31, 2019, and provided a corporate update (Press release, Lipocine, MAY 8, 2019, View Source [SID1234535927]).

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First Quarter and Recent Corporate Highlights

·Announced findings from the Ambulatory Blood Pressure Monitoring clinical study (NCT03868059) ("ABPM Study") designed to study TLANDO’s effects on blood pressure. The results appear in line with recently approved testosterone replacement therapy.
·Announced top-line results from the 16-week Liver Fat Imaging Study ("Liver Fat Study") with LPCN 1144, designed to assess the therapeutic potential of LPCN 1144 in non-alcoholic steatohepatitis ("NASH"). Treatment results demonstrated that 48% of the treated subjects had NAFLD resolution at the end of the study. Additionally, 100% of the subjects experiencing NAFLD resolution had at least a 35% relative liver fat reduction from baseline with a relative mean liver fat reduction of 55% in this group.
·LPCN 1144 featured in late-breaker presentation at the EASL International Liver Conference, demonstrating reduction of liver fat (measured using magnetic resonance imaging, proton density fat fraction or "MRI-PDFF") and improvement in key serum biomarkers typically associated with NASH.
·Poster highlighting therapeutic potential of LPCN 1144 in NAFLD and NASH presented at ENDO 2019 meeting.
·Received clearance by the U.S. Food and Drug Administration ("FDA") for an Investigational New Drug ("IND") application to initiate a Phase 2 clinical study of LPCN 1144 in patients with biopsy confirmed NASH.
· Filed suit against Clarus Therapeutics, Inc. ("Clarus") in the United States District Court alleging that Clarus’s JATENZO product infringes six of Lipocine’s U.S. patents.

"We achieved important milestones in Lipocine’s most advanced clinical programs during the first quarter of 2019, and in recent weeks," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. Dr. Patel further stated, "With the successful completion of the ABPM study for TLANDO, we look forward to resubmitting our NDA for TLANDO in May 2019. We announced positive 16-week results from the Liver Fat Study of LPCN 1144 and have received clearance from the FDA to initiate a Phase 2 clinical study of LPCN 1144 in patients with biopsy confirmed NASH."

First Quarter Ended March 31, 2019 Financial Results

Lipocine reported a net loss of $3.2 million, or ($0.14) per diluted share, for the quarter ended March 31, 2019, compared with a net loss of $2.7 million, or ($0.13) per diluted share, in the quarter ended March 31, 2018.

Research and development expenses were $1.9 million for the quarter ended March 31, 2019, compared with $1.4 million for the quarter ended March 31, 2018. The increase in research and development expenses was primarily due to increased contract research organization costs for TLANDO in connection with the ABPM Study, offset by decreases in outside service costs primarily related to the January 2018 TLANDO BRUDAC meeting, decreases in contract manufacturing costs related to LPCN 1107, and decreases in personnel costs.

General and administrative expenses were $1.2 million for the quarter ended March 31, 2019, compared with $1.7 million for the quarter ended March 31, 2018. The decrease in general and administrative expenses was primarily due to decreased personnel costs, decreased professional fees offset by an increase in other administrative costs related to overhead.

As of March 31, 2019, the Company had unrestricted and restricted cash, cash equivalents and marketable securities aggregating $22.5 million, compared to $20.3 million at December 31, 2018. The $5.0 million of restricted cash, cash equivalents and marketable securities becomes unrestricted upon approval of TLANDO by the FDA.

On May 8, 2019 Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) reported its first quarter 2019 financial results and highlights (Press release, Synta Pharmaceuticals, MAY 8, 2019, View Source [SID1234535926]):

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"Madrigal continued to make significant progress in the first quarter of 2019, initiating a Phase 3 study of MGL-3196 (resmetirom) in patients with biopsy-proven non-alcoholic steatohepatitis (NASH) and liver fibrosis (MAESTRO-NASH)," stated Paul Friedman, M.D., Chief Executive Officer of Madrigal. "We also look forward to advancing our planned Phase 3 clinical trial in patients with NAFLD/NASH and dyslipidemia in the latter half of this year."

Becky Taub, M.D., CMO and Executive VP, Research & Development of Madrigal added, "An experienced group of NASH investigators and clinical sites around the world are participating in MAESTRO-NASH, and we are encouraged regarding timely enrollment. We believe the pleiotropic effects of resmetirom provide the potential to resolve NASH and improve liver fibrosis, and in addition, by reducing the levels of multiple atherogenic lipids and liver fat, also reduce cardiovascular risk."

Additional information about Madrigal’s Phase 3 study in patients with NASH [NCT03900429] can be obtained at www.clinicaltrials.gov.

Financial Results for the Three Months Ended March 31, 2019

As of March 31, 2019, Madrigal had cash, cash equivalents and marketable securities of $477.8 million, compared to $483.7 million at December 31, 2018. Cash used in operating activities during the first quarter of 2019 was $6.5 million.

Operating expenses were $18.1 million for the three month period ended March 31, 2019, compared to $7.1 million in the comparable prior year period.

Research and development expenses for the three month period ended March 31, 2019 were $12.4 million compared to $5.2 million in the comparable prior year period. The increase is primarily attributable to additional activities related to initiation of our Phase 3 clinical trial in NASH, including an increase in headcount and increased non-cash stock compensation from stock option awards.

General and administrative expenses for the three month period ended March 31, 2019 were $5.7 million compared to $1.9 million in the comparable prior year period. The

increase is due primarily to higher non-cash stock compensation expense from stock option awards.

Interest income for the three month period ended March 31, 2019 was $3.0 million compared to $705 thousand in the comparable prior year period. The change in interest income was due primarily to a higher average principal balance in our investment portfolio in 2019, and increased interest rates.

About resmetirom (MGL-3196)

Among its many functions in the human body, thyroid hormone, through activation of its beta receptor, plays a central role in controlling lipid metabolism, impacting a range of health parameters from levels of serum cholesterol and triglycerides to the pathological buildup of fat in the liver. Attempts to exploit this pathway for therapeutic purposes in cardio-metabolic and liver diseases have been hampered by the lack of selectivity of older compounds for the thyroid hormone receptor (THR)-β, chemically-related toxicities and undesirable distribution in the body.

Madrigal recognized that greater selectivity for thyroid hormone receptor (THR)-β and liver targeting might overcome these challenges and deliver the full therapeutic potential of THR-β agonism. Madrigal believes that resmetirom is the first orally administered, small-molecule, liver- directed, truly β-selective THR agonist.

Based on the positive Phase 2 clinical study results in patients with NASH (Phase 2 36-Week Results Press Release), Madrigal recently announced the initiation of a Phase 3 multinational, double-blind, randomized, placebo-controlled study of resmetirom in patients with non-alcoholic steatohepatitis (NASH) and fibrosis to resolve NASH and reduce progression to cirrhosis and/or hepatic decompensation (Phase 3 Initiation Press Release and ClinicalTrials.gov NCT03900429). Additionally, in both the NASH Phase 2 study, and a second positive Phase 2 clinical study in patients with heterozygous familial hypercholesterolemia (Phase 2 HeFH Results Press Release), significant reductions in multiple atherogenic lipids were observed. As a result, Madrigal is designing a Phase 3 study intended to treat the prevalent dyslipidemias in NAFLD and NASH patients and improve the fatty liver phenotype in this population.

On May 8, 2019 EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, reported financial results for the first quarter ended March 31, 2019, and highlighted recent corporate developments (Press release, pSivida, MAY 8, 2019, View Source [SID1234535925]).

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"The initial launches of our two commercial ocular products, DEXYCUTM and YUTIQTM, have generated a strong initial reception by treating physicians and patients, which we will look to leverage to drive sales growth in the coming quarters," said Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals. "We are now a fully-integrated, commercial-stage specialty ophthalmology company and are very pleased with the early momentum we are seeing for our two new innovative ocular products, each of which have significant market potential. We are also optimistic that we are well-positioned financially to execute on our goals following the addition of a new credit facility in February with CRG and the recent equity offering that we completed in April to support our operations through to positive cash flow in 2020."

Recent Highlights

YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye was made commercially available on February 4, 2019. YUTIQ received a preliminary recommendation from the Centers for Medicare & Medicaid Services (CMS) for a specific J-code through the Healthcare Common Procedure Coding System (HCPCS).

Ten Key Account Managers (KAMs) are dedicated to calling predominantly uveitis specialists across the U.S.

Since the February launch, approximately 95% of the top decile uveitis specialists have been visited by 10 KAMs.

Since launch, over 100 YUTIQ orders have been shipped for use in patients.

Over 300 benefit investigations have been received.

YUTIQ has been included in 9 academic formularies and is pending inclusion for an additional 11.

As of April 30, our market access initiatives have resulted in over 93% of commercial lives covered, over 75% of Medicare Advantage lives covered and 95% of Medicare Fee-For-Service lives covered.

DEXYCU (dexamethasone intraocular suspension) 9% for the treatment of post-operative inflammation following cataract surgery was made commercially available on March 12, 2019.

34 KAMs dedicated to the promotion of DEXYCU have focused on a phased launch program to ensure proper physician training for the preparation, application and administration of DEXYCU.

Since launch, nearly 200 surgeons in more than 150 ambulatory surgical centers (ASCs) have completed the training/certification program and are now able to purchase DEXYCU.

Since launch, over 1,200 patients have been injected with DEXYCU via the Company’s sampling program.

Since launch, over 2,000 medical professionals and office staff have been called on to discuss DEXYCU.

As of April 30, our market access initiatives have resulted in over 90% of commercial lives covered, over 75% of Medicare Advantage lives covered and 100% of Medicare Fee-For-Service lives covered.

At the 2019 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Vancouver, British Columbia, 36-month efficacy and safety data supporting YUTIQ was presented in an oral session entitled, "Treatment of Non-infectious Uveitis that Affects the Posterior Segment with a Single Intravitreal Fluocinolone Acetonide Insert (FAi) – 3-year Results." The 36-month follow up data of the Phase 3 clinical trial of YUTIQ showed a 56.3% recurrence rate of uveitis eye flares, significantly lower than eyes treated with sham (92.9%). The p-value was <0.001. 19.5% of YUTIQ treated eyes needed the assistance of adjunctive intraocular/periocular injection medication for uveitic inflammation compared to 69.0% for sham treated eyes. 34.5% of YUTIQ treated eyes needed the assistance of an adjunctive systemic steroid or immunosuppressant compared to 50.0% for sham treated eyes. Intraocular pressure (IOP) lowering drops were used in 42% of YUTIQ treated eyes and 33% of sham treated eyes with IOP lowering surgeries performed in 6% of YUTIQ treated eyes and 12% of sham treated eyes. Safety and side effects were consistent with those reported for previous analyses of earlier timepoints. These durable 36-month results continue to reinforce the potential of YUTIQ as a long-acting treatment option for patients suffering from this chronic disease.

At the 2019 American Society of Cataract and Refractive Surgery (ASCRS) and American Society of Ophthalmic Administrators (ASOA) Annual Meeting in San Diego, California, data supporting DEXYCU was presented in a paper session entitled, "Effect of Dexamethasone Intraocular Suspension 9% on IOP after Cataract Surgery: Results of Two Phase 3 Studies." An analysis of the IOP data from two Phase 3 studies of DEXYCU showed that the IOP effect of DEXYCU was comparable to short-term topically administered prednisolone acetate or placebo in cataract surgery patients. Mean IOP was only slightly elevated, to approximately 19 and 18 mmHg at postoperative Day 1 in the DEXYCU and prednisolone acetate arms, respectively, and it returned to baseline in both arms by Day 3. The proportion of patients at each measured IOP category in both studies were similar between the DEXYCU and control group cohorts. These data further support DEXYCU’s safety profile for the treatment of post-operative inflammation.

On April 1, 2019, the Company completed a public offering of 10,526,500 shares of its common stock at a public offering price of $1.90 per share. The net proceeds of the offering to the Company were approximately $18.6 million.

During April 2019, the Company exercised its option to draw an additional $15.0 million under the CRG Loan Agreement and paid a $15.0 million development milestone that was due to the former Icon security holders following the first commercial sale of DEXYCU. At April 30, 2019, the Company had $56.9 million of cash and cash equivalents.

Review of First Quarter Results Ended March 31, 2019

For the three months ended March 31, 2019, total net revenue was $2.0 million compared to $928,000 for the three months ended March 31, 2018. Net revenue from DEXYCU was $684,000, and for YUTIQ net revenue was $543,000. Neither of these products had net revenue in the corresponding quarter in 2018. Net revenue from royalties and collaborations for the three months ended March 31, 2019 totaled $785,000 compared to $928,000 in the corresponding quarter in 2018.

Operating expenses for the three months ended March 31, 2019 increased to $16.7 million from $5.6 million in the prior year period, due primarily to investments in sales and marketing infrastructure and program costs, professional services, stock-based compensation and amortization of the DEXYCU intangible asset. Non-operating expense, net, for the three months ended March 31, 2019 totaled $4.6 million and consisted of $777,000 of net interest expense and $3.8M from the loss on extinguishment of debt related to the pay off of the SWK term loan. Net loss for the three months ended March 31, 2019 was $19.2 million, or $0.20 per share, compared to a net loss of $7.0 million, or $0.15 per share, for the prior year quarter.

Cash and cash equivalents at March 31, 2019 totaled $43.4 million compared to $45.3 million at December 31, 2018. At April 30, 2019, the total amount outstanding under the CRG debt facility was $50 million and cash and cash equivalents as of that date were $56.9 million.

Financial Outlook

Early sales of YUTIQ and DEXYCU have been encouraging, and the Company is optimistic that existing cash and cash equivalents at April 30, 2019, and cash inflows from anticipated YUTIQ and DEXYCU product sales, will be sufficient to fund the Company’s current and planned operations through to the generation of positive cash flow in 2020.

Conference Call Information

EyePoint will host a conference call today, Wednesday, May 8, 2019, at 8:30 AM ET to discuss the results for the first quarter ended March 31 and recent operational developments. To access the conference call, please dial (877) 312-7507 from the U.S. and Canada or (631) 813-4828 (international) at least 10 minutes prior to the start time and refer to conference ID 1192368. A live webcast will be available on the Investor Relations section of the corporate website at View Source A replay of the webcast will also be available on the corporate website.

On May 8, 2019 Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) reported financial results for the three months ended March 31, 2019 and provided a corporate update (Press release, Portola Pharmaceuticals, MAY 8, 2019, View Source [SID1234535924]).

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"Our first quarter results continue to reflect strong demand for Andexxa, as well as focused execution on our commercial launch. The full commercial U.S. launch of Andexxa is off to a great start, and with approval of Ondexxya in Europe, we now have another long-term growth catalyst and the ability to impact thousands of additional patient lives," said Scott Garland, Portola’s president and chief executive officer. "Additionally, we continue to make progress with cerdulatinib and look forward to further defining the safety and efficacy profile, along with that of Andexxa, in a number of scientific presentations anticipated in Q2."

Quarter Ending March 31, 2019

Total revenues for the first quarter of 2019 were $22.2 million, compared with $6.6 million for the first quarter of 2018. This includes $20.3 million in net product revenues from Andexxa sales, $77 thousand in revenues from Bevyxxa sales and $1.8 million in collaboration and license revenues. Please see the tables at the end of this press release for a detailed breakdown of revenues.

Net loss attributable to Portola, according to generally accepted accounting principles in the U.S. (GAAP), was $78.2 million for the first quarter of 2019, or $1.17 net loss per share, compared with a net loss of $84.2 million, or $1.28 net loss per share, for the same period in 2018. This includes the effect of two charges taken in the first quarter related to the FDA approval for the Company’s Gen 2 manufacturing process. The first is a $5.8 million charge associated with the valuation of the Company equity that will be issued to Lonza, our Andexxa Gen 2 manufacturer ("manufacturing site charge"), and the second is a $3.9 million charge associated with the Andexxa Gen 1 product as hospitals transition to the Gen 2 product ("Gen 1 supply charge").

Non-GAAP net loss for the first quarter of 2019 was $68.4 million, or a non-GAAP basic and diluted loss per share of $1.02. Non-GAAP net loss and net loss per share have been adjusted to remove the manufacturing site charge and the Gen 1 supply charge. Please see the reconciliation of GAAP to non-GAAP financial measures at the end of this release for more details.

Cash, cash equivalents and investments at March 31, 2019 totaled $322.8 million, compared with $317.0 million as of December 31, 2018. In March, the Company entered into a $125 million loan agreement and received an initial tranche of $62.5 million, with the balance available at Portola’s option in the third quarter, subject to certain conditions, extending our cash runway to the end of 2020.

Total operating expenses for the first quarter of 2019 were $95.8 million, compared with $91.9 million for the same period in 2018. The increase was driven by the timing of launch activities in the U.S., the build-out of the Company’s field force and launch preparations in Europe.

Non-GAAP total operating expenses, which excludes the two charges outlined above, were $86.0 million for the first quarter of 2019. Please see the reconciliation of GAAP to non-GAAP financial measures table at the end of this release for more details.

Stock-based compensation expense for the first quarter of 2019 was $17.9 million, compared with $11.0 million for the same period in 2018. This year-over-year increase was driven primarily by the equity issued for the manufacturing site charge.

Cost of Sales (COS) for the first quarter of 2019 were $7.2 million, compared to $336 thousand for the same period in 2018. The increase was driven by the launch of Andexxa and the Gen 1 supply charge.

Research and development (R&D) expenses were $35.6 million for the first quarter of 2019, compared with $60.1 million for the first quarter of 2018. The decrease was driven primarily by the manufacturing costs for Andexxa Gen 2 being capitalized and no longer flowing through R&D.

Selling, general and administrative (SG&A) expenses for the first quarter of 2019 were $53.0 million, compared with $31.5 million for the same period in 2018. The increase was driven by the expansion of the Company’s field force, commercial activities to support the launch of Andexxa and launch preparations in Europe.

Recent Achievements and Events

Received European Commission approval of Ondexxya and hired Head of Europe to build a team to support planned commercial activity.

Received C-code from The Centers for Medicare & Medicaid Services, allowing hospitals an additional reimbursement pathway for Andexxa.

Submitted additional data to the U.S. Food and Drug Administration on the proposed dose for cerdulatinib.

Announced the retirements of Portola co-founder Charles Homcy, M.D. from the Board of Directors, and John Curnutte, M.D., Ph.D., Executive Vice President of Research and Development.

Upcoming Milestones

Staged launch of Ondexxya in a select group of high-potential European countries where Factor Xa use is among the highest.

Present new data on:

The impact of Andexxa on patients with an intracranial hemorrhage at the European Stroke Organization Conference in Milan in May.

The question of whether PCCs have clinical activity in the reversal of direct FXa inhibitors at the International Society of Thrombosis and Hematology meeting in Melbourne.

The safety and efficacy of cerdulatinib in relapsed/refractory follicular lymphoma, either alone or in combination with rituximab.

Initiate discussions with the FDA on a number of potential label expansion opportunities including the addition of the ANNEXA-4 efficacy data, the inclusion of edoxaban and enoxaparin, and the potential initiation of a study in urgent surgery.

Conference Call Details

Portola will host a conference call today, Wednesday, May 8, 2019, at 8:30 a.m. ET, during which time management will discuss the first quarter 2019 financial results, updates on the U.S. launch of Andexxa, launch preparations in Europe and other matters. The live call can be accessed by phone by dialing (844) 452-6828 from the U.S. and Canada or 1 (765) 507-2588 internationally and using the passcode 1684446. The webcast can be accessed live on the Investor Relations section of the Company’s website at View Source It will be archived for 30 days following the call.

Use of Non-GAAP Financial Measures

This press release and the reconciliation table included herein include non-GAAP net loss, non-GAAP basic and diluted loss per share and non-GAAP operating expenses. The Company believes the presentation of non-GAAP financial measures provides useful information to management and investors regarding the company’s financial condition and results of operations. When viewed in conjunction with GAAP financial measures, investors are provided with a more meaningful understanding of the Company’s ongoing operating performance and are better able to compare the Company’s performance between periods. In addition, these non-GAAP financial measures are among those that the Company uses as a basis for evaluating performance, allocating resources and planning and forecasting future periods. Non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation of GAAP to non-GAAP financial measures is provided in the accompanying table entitled "Reconciliation of GAAP to Non-GAAP Financial Measures."

On May 8, 2019 BioNTech SE, a clinical-stage biotechnology company focused on patient-specific immunotherapies for the treatment of cancer and other serious diseases, reported the acquisition of antibody assets and infrastructure from San Diego-based MabVax Therapeutics Holding, Inc. (Nasdaq: MBVX), a clinical-stage oncology drug development company (Press release, BioNTech, MAY 8, 2019, View Source [SID1234535923]).

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Under the terms of the agreement, BioNTech has acquired MabVax Therapeutics’ lead candidate, MVT-5873, as well as other pre-clinical antibody assets to expand and complement its existing antibody portfolio and proprietary RiboMABS development capabilities. The acquired lead asset is currently in Phase 1 clinical development in pancreatic cancer and has been tested in 35 patients with initial positive interim data announced in February 2018. MVT-5873 is a fully human IgG1 monoclonal antibody targeting sialyl Lewis A (sLea), an epitope expressed in pancreatic and other GI cancers that plays a role in tumor adhesion and metastasis formation.

"BioNTech’s vision is to identify and provide the best therapeutic options for each individual cancer patient. To make this possible, we are developing and integrating complementary technologies and drug modalities into our overall portfolio of treatment approaches," said Prof. Dr. Ugur Sahin, CEO of BioNTech. "MabVax Therapeutics has developed an antibody with a novel mode of action in a disease indication that complements our pipeline expansion plans. This clinical-stage antibody together with the other pre-clinical assets that we have acquired from MabVax Therapeutics enhance our antibody portfolio, which also benefits from our ongoing collaboration with Genmab and the acquisition of MAB Discovery earlier this year."

In conjunction with the agreement, BioNTech has purchased MabVax Therapeutics’ infrastructure and laboratory equipment with the intention of establishing a research facility in San Diego. The location is advantageous for BioNTech’s planned US-based clinical trials and will further support production of the Company’s investigational treatments. Financial terms were not disclosed.