On May 6, 2021 Vincerx Pharma, Inc. (Nasdaq: VINC) (the "Company"), reported the completion of its redemption event with respect to its outstanding public warrants (the "Public Warrants") (Press release, Vincerx Pharma, MAY 6, 2021, View Source [SID1234579384]).

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The Company issued a press release on April 5, 2021, stating that it would redeem all of its outstanding Public Warrants to purchase shares of the Company’s common stock, $0.0001 par value per share ("Common Stock"), that were issued under the Warrant Agreement, dated as of March 5, 2020 (the "Warrant Agreement"), by and between the Company and Continental Stock Transfer & Trust Company, as warrant agent (the "Warrant Agent"), that remained outstanding and unexercised at 5:00 p.m. New York City time on May 5, 2021 (the "Redemption Date") for a redemption price of $0.01 per Public Warrant (the "Redemption Price").

Of the 6,563,767 Public Warrants initially issued by the Company, 6,491,604 were exercised in aggregate, representing approximately 99% of the exercisable Public Warrants, with the remaining 72,163 unexercised Public Warrants redeemed by Vincerx.

Total cash proceeds generated from warrant exercises were approximately $37.3 million.

Total shares of Common Stock outstanding as of close of business on May 5, 2021, were 17,505,239.

On May 6, 2021 Magenta Therapeutics (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplants to more patients, reported financial results for the first quarter ended March 31, 2021 and recent program highlights (Press release, Magenta Therapeutics, MAY 6, 2021, View Source [SID1234579383]).

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"Magenta continues to make progress across our program portfolio, building momentum towards several key anticipated clinical and data milestones throughout 2021, including the initial Phase 2 trial results evaluating MGTA-145 plus plerixafor in Multiple Myeloma patients in an autologous transplant setting and filing an IND for first-in-human Phase 1/2 clinical trial of MGTA-117, our first product candidate from our targeted conditioning platform," said Jason Gardner, D.Phil., President and Chief Executive Officer, Magenta Therapeutics. "We are optimistic about our programs’ ability to transform clinical practice of stem cell transplants and gene therapies with new first-line medicines, which we believe could increase access to curative transplants across multiple disease areas."

Program Highlights:

MGTA-145 Upcoming Scientific Conference Presentations:

Magenta will present preliminary MGTA-145 Phase 2 data in Multiple Myeloma patients at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held virtually June 4-8, 2021, and at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress, to be held virtually June 9-17, 2021.
MGTA-145 Stem Cell Mobilization and Collection

Recent and Planned Activity:

Phase 2 clinical trial in Multiple Myeloma is ongoing at Stanford University, evaluating the ability of MGTA-145, in combination with plerixafor, to mobilize stem cells for collection prior to autologous stem cell transplant. This 25-patient, investigator-initiated trial will also measure engraftment and disease outcome measures, with stem cell mobilization as the primary endpoint. Preliminary results will be presented at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) and final clinical data from this trial are expected in the second half of 2021.
Phase 2 clinical trial in collaboration with the National Marrow Donor Program/Be The Match, evaluating MGTA-145, in combination with plerixafor, in the mobilization and collection of stem cells from allogeneic donors for transplant in patients with Acute Myeloid Leukemia (AML), Acute Lymphocytic Leukemia (ALL) and Myelodysplastic Syndromes (MDS). Initial data from this trial are expected in the second half of 2021.
Initiate Phase 2 clinical trial in Sickle Cell Disease in collaboration with bluebird bio in the second half of 2021 to evaluate the utility of MGTA-145, in combination with plerixafor, for the mobilization and collection of stem cells in patients with Sickle Cell Disease where mobilization and collection is difficult and there is a clear unmet medical need.

MGTA-117 and CD45-ADC Targeted Conditioning Programs

Recent and Planned Activity:

MGTA-117 Investigational New Drug (IND) filing anticipated mid-2021. If the IND is accepted by the FDA, Magenta plans to initiate a Phase 1/2 clinical trial evaluating MGTA-117 in patients with AML and MDS. Magenta expects to assess initial safety and pharmacokinetic data internally in the fourth quarter of 2021, and also expects to be able to provide an update regarding the study’s progress within the dose escalation study design.
Magenta recently completed its GLP toxicology studies, its GMP manufacturing process and has finished its pre-IND communications with the FDA.
Financial Results:

Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2021, were $132.3 million, compared to $148.8 million as of December 31, 2020. Magenta anticipates that its cash, cash equivalents and marketable securities will be sufficient to fund operations and capital expenditures into the first quarter of 2023.

Research and Development Expenses: Research and development expenses were $11.7 million in the first quarter of 2021, compared to $14.0 million in the first quarter of 2020. The decrease was driven primarily by the completion of the GMP manufacturing campaign to support the upcoming IND for MGTA-117, and the discontinuation of the Phase 2 trial of MGTA-456 in inherited metabolic diseases in June 2020.

General and Administrative Expenses: General and administrative expenses were $7.0 million for the first quarter of 2021, compared to $7.3 million for the first quarter of 2020.

Net Loss: Net loss was $17.5 million for the first quarter of 2021, compared to net loss of $20.0 million for the first quarter of 2020.

On May 6, 2021 XOMA Corporation (Nasdaq: XOMA) reported its first quarter 2021 financial results and provided a recent operations update (Press release, Xoma, MAY 6, 2021, View Source [SID1234579382]).

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"Our team continues to identify exciting assets to add to our milestone and royalty portfolio. Their efforts resulted in our acquisition of two economic licenses from Viracta during the first quarter. We were delighted to add Day One Biopharmaceuticals’ DAY101 (pan-RAF kinase inhibitor) and Denovo Biopharma’s vosaroxin (topoisomerase II inhibitor) to our growing list of partner-funded assets," stated Jim Neal, Chief Executive Officer of XOMA. "I am proud that our team continues to be productive in this COVID-impacted environment.

"In addition, since the close of the first quarter, we added three clinical-stage assets to our portfolio, AFM13, AFM24, and an undisclosed asset, each of which resulted from a research and discovery license agreement we established with Affimed fifteen years ago. These are three interesting oncology assets as they are designed to activate the body’s innate immune system to kill cancer cells. We believe the initial data from the AFM13 Phase 1 study in patients with relapsed/refractory CD30+ lymphomas, recently presented at the AACR (Free AACR Whitepaper) Virtual Annual Meeting, are encouraging. This week, we received notification from Janssen that the first patient has been dosed in the inaugural cetrelimab Phase 3 clinical study, making it the second molecule in our portfolio to advance to the final stage of clinical development.

"To continue to support our strategy to expand our potential milestone and royalty portfolio via acquisition transactions, in April we completed a $40 million offering of Series B Perpetual Preferred Stock, which pays an 8.375% dividend, bringing our cash and restricted cash to over $100 million. And finally, we paid our first dividend on the Series A Perpetual Preferred Stock. Today, we have one of the strongest financial positions in our recent history, particularly when coupled with our very lean expense structure."

Financial Results

XOMA recorded total revenues of $0.4 million for the first quarter of 2021, compared to $0.8 million for the first quarter of 2020. The decrease for the three months ended March 31, 2021, as compared to the same period in 2020, was primarily due to $0.5 million in revenue recognized in the first quarter of 2020 related to a milestone event under XOMA’s license agreement with Compugen.

Research and development expenses were $0.1 million for the first quarter of 2021, compared to $0.1 million for the first quarter of 2020.

General and administrative ("G&A") expenses were $6.7 million for the first quarter of 2021, compared to $6.4 million for the first quarter of 2020. The increase of $0.3 million for the three months ended March 31, 2021, as compared to the same period of 2020, was primarily due to a $1.4 million increase in salary and related expenses (including an increase of $1.1 million in non-cash stock compensation expense) and $0.3 million increase in consulting and deal costs, partially offset by a $1.4 million decrease in bad debt expense.

In the first quarter of 2021, G&A expenses included $2.9 million in stock-based compensation expense compared with $1.8 million in the corresponding quarter of 2020. The increase in expense was primarily due to an increase in the fair value of options granted driven by an increase in our stock price. In the first quarter of 2020, non-cash G&A expenses also included $1.4 million in bad debt expense. The Company’s net cash used in operations in the first quarter of 2021 was $0.9 million, as compared with $2.3 million during the first quarter of 2020.

In the first quarter of 2021, XOMA recorded $0.3 million in total interest expense, as compared to $0.5 million in the corresponding period of 2020, both of which reflect the Company’s outstanding loan balances with Silicon Valley Bank and Novartis.

For the quarter ended March 31, 2021, XOMA recorded total other expense of $0.7 million, which included a $0.7 million change in the fair value of equity securities. For the quarter ended March 31, 2020, XOMA reported total other expense of $0.1 million, which included a $0.3 million change in the fair value of equity securities offset by $0.1 million in investment income.

In the first quarter of 2020, XOMA recorded an income tax benefit of $1.5 million as a result of a provision regarding net operating loss carrybacks within the CARES Act.

Net loss for the first quarter of 2021 was $7.4 million, compared to net loss of $4.8 million for the first quarter of 2020.

On March 31, 2021, XOMA had cash of $67.8 million. The Company ended December 31, 2020, with cash of $84.2 million. On April 12, 2021, XOMA announced the closing of its Depositary Shares Offering and the exercise of the underwriters’ option, which resulted in approximately $38.0 million after deducting underwriting discounts and commissions, but before expenses. On April 15, 2021, the Company paid its first dividend on Series A Cumulative Perpetual Preferred (Nasdaq: XOMAP) in the amount of $0.71875 per share. The Company continues to believe its current cash position will be sufficient to fund XOMA’s operations for multiple years.

On May 6, 2021 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), a clinical-stage biotechnology company developing eganelisib, a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic that addresses a fundamental biologic mechanism of immune suppression in cancer, reported that it will host a conference call on Thursday, May 13th 2021 at 4:30pm ET to report its financial results for the first quarter of 2021 (Press release, Infinity Pharmaceuticals, MAY 6, 2021, View Source [SID1234579381]).

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A live webcast of the conference call can be accessed in the Investors/Media section of Infinity’s website at www.infi.com and will be available on Infinity’s website for 30 days following the event.

On May 6, 2021 BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio or the Company), a commercial-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic driverse reported its financial results for the first quarter ended March 31, 2021 and provided an update on the Company’s operations (Press release, BridgeBio, MAY 6, 2021, View Source [SID1234579380]).

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"We measure success by the number of meaningful medicines we are able to develop and deliver to patients. Our first FDA approval in February was a significant milestone for us as a company, but more importantly marked a turning point for MoCD Type A patients and their families, who now have an approved therapy for the first time," said BridgeBio CEO and founder Neil Kumar, Ph.D. "We hit the first of four major clinical data readouts anticipated over the next 12 months, reporting proof-of-concept data for encaleret in ADH1 that offers promise to patients in need. And we entered into a partnership with Helsinn Group, designed to help us reach as many patients as possible living with FGFR-driven cancers through our anticipated upcoming launch of infigratinib."

Major milestones anticipated in 2021 or early 2022 for BridgeBio’s four core value drivers:

Acoramidis (AG10) – Transthyretin (TTR) stabilizer for transthyretin amyloid cardiomyopathy (ATTR-CM): Topline results from Part A of the ATTRibute-CM trial are expected in late 2021 or early 2022 and from Part B in 2023. If Part A is successful, BridgeBio expects to submit an application for regulatory approval of acoramidis in 2022. ATTR is a form of amyloidosis caused by the accumulation of misfolded TTR protein. It is estimated to affect more than 400,000 people worldwide and is largely undiagnosed today.
Encaleret – Calcium-sensing receptor (CaSR) inhibitor for ADH1: Early results from an ongoing Phase 2 proof-of-concept study shared at the Endocrine Society’s 2021 Annual Meeting (ENDO) in March 2021 showed normalization of blood calcium and urine calcium in 6 of 6 (100%) ADH1 participants. If the development program is successful, encaleret could be the first approved therapy for ADH1, a condition caused by gain of function variants in the CaSR gene estimated to be carried by 12,000 individuals in the United States alone.
Low-dose infigratinib – FGFR1-3 inhibitor for achondroplasia: Initial data from the ongoing Phase 2 dose ranging study are expected by the end of 2021. Achondroplasia is the most common form of genetic short stature and one of the most common genetic diseases, with a prevalence of greater than 55,000 cases in the United States and European Union. Low-dose infigratinib is the only known product candidate in clinical development for achondroplasia that targets the disease at its genetic source and the only orally administered product candidate in clinical-stage development.
BBP-631 – AAV5 gene therapy candidate for congenital adrenal hyperplasia (CAH): Investigational New Drug (IND) application cleared by the FDA and site activation for initiation of a first-in-human Phase 1/2 study is ongoing, with initial data anticipated in late 2021 or early 2022. CAH is one of the most prevalent genetic diseases potentially addressable with AAV gene therapy, with more than 75,000 cases estimated in the United States and European Union. The disease is caused by deleterious mutations in the gene encoding an enzyme called 21-hydroxylase, leading to lack of endogenous cortisol production. BridgeBio’s AAV5 gene therapy candidate is designed to provide a functional copy of the 21-hydroxylase-encoding gene (CYP21A2) and potentially address many aspects of the disease course.
Recent pipeline progress and corporate updates:

Received FDA approval for NULIBRY (fosdenopterin) for injection in February 2021 as the first therapy to reduce the risk of mortality in patients with MoCD Type A, an ultra-rare, life-threatening genetic disorder that progresses rapidly, results in severe and largely irreversible neurological injury, and has a high infant mortality rate.
Launched strategic collaboration with Helsinn Group in March 2021 to co-develop and commercialize infigratinib in oncology. The Company is eligible to receive up to approximately $2.45 billion USD, including over $100.0 million USD in upfront, regulatory and launch milestone payments, and the remainder subject to the achievement of specified commercial milestones, and retains full rights to infigratinib for use in skeletal dysplasias, including for achondroplasia.
Completed acquisition of Eidos Therapeutics in January 2021, acquiring of all of the outstanding shares of Eidos common stock that BridgeBio did not already own.
Raised nearly $750 million in gross proceeds in February 2021 through issuance of 2.25% Convertible Senior Notes due in 2029. The Company expects current cash, cash equivalents and marketable securities to support its planned operations into 2023.
The Phase 3 clinical trial of topical patidegib gel in patients with Gorlin Syndrome, advanced by BridgeBio affiliate PellePharm, failed to meet primary and secondary endpoints, but showed multiple signals of potential activity. Accordingly, the Phase 2 study in high-frequency basal cell carcinoma is being halted. The open-label extension (OLE) study is being continued at present at the behest of the patient foundations and physician leaders in the field. LEO Pharma, which entered into a strategic collaboration with PellePharm in 2018, has terminated its option to acquire PellePharm. PellePharm is currently evaluating its data and engaging the applicable regulatory authorities and potential strategic partners to determine next steps.
Dosed first patient in Phase 2 trial of BBP-418 in Limb-Girdle Muscular Dystrophy Type 2i in February 2021.
Dosed first healthy volunteer in Phase 1 trial of BBP-671, being developed for the treatment of pantothenate kinase-associated neurodegeneration (PKAN) and organic acidemias (OA), in April 2021.
Announced formal partnerships in March 2021 with Brown University, University of California, San Diego, GlycoNet, The Lundquist Institute, Oregon Health & Science University, Roswell Park Comprehensive Cancer Center and University of California, Davis – for a total of 20 partnerships among BridgeBio and leading academic and research institutions to date.
First Quarter 2021 Financial Results:

Cash, Cash Equivalents and Marketable Securities

Cash, cash equivalents and marketable securities, excluding restricted cash, totaled $1,001.3 million as of March 31, 2021, compared to $607.1 million as of December 31, 2020. The net increase in balance of $394.2 million is attributed to $731.4 million in net proceeds received from the issuance of our 2.25% Convertible Senior Notes due 2029 (2029 Notes), offset by a $61.3 million payment related to capped call options and a $50.0 million payment to repurchase shares of BridgeBio common stock, both in relation to the issuance of our 2029 Notes. In connection with our acquisition of Eidos, we also paid $59.1 million in direct transaction costs and $21.3 million to Eidos stockholders who elected cash settlement. The remaining change of $145.5 million primarily related to payments of interest and operating expenses.

Operating Expenses

Operating expenses for the three months ended March 31, 2021 were $168.0 million as compared to $102.5 million for the same period in the prior year. The increase in operating expenses of $65.5 million during the period is attributable to the increase in personnel costs resulting from an increase in the number of employees to support the progression in our research and development programs, including our increasing research pipelines, as well as an increase in stock-based compensation related to the achievement of various performance-based milestone compensation arrangements tied to regulatory and development milestones. Stock-based compensation for the three months ended March 31, 2021 was $34.9 million as compared to $10.2 million for the same period in the prior year.

Our research and development expenses have not been significantly impacted by the global outbreak of COVID-19 for the periods presented. While we experienced some delays in certain of our clinical enrollment and trial commencement activities, we continue to adapt in this unprecedented time to enable alternative site, telehealth and home visits, at-home drug delivery, as well as mitigation strategies with our contract manufacturing organizations. The longer-term impact, if any, of COVID-19 on our operating expenses is currently unknown.