On August 12, 2021 Calliditas Therapeutics AB (publ) ("Calliditas" or the "Company") (Nasdaq Stockholm – CALTX; Nasdaq – CALT), a biopharma company focused on identifying, developing and commercializing novel treatments in orphan indications, reported, in accordance with the Company’s press release earlier today, the closing of a directed share issue consisting of 2,400,000 common shares at a price of SEK 135 per share (the "Issue") (Press release, Calliditas Therapeutics, AUG 12, 2021, View Source [SID1234586456]). The Issue will raise proceeds for the Company of approximately SEK 324 million before transaction costs. The subscription price in the Issue has been determined through an accelerated book building procedure.

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The Issue in brief

The Board of Directors of Calliditas has, in accordance with the issue authorization granted by the Annual General Meeting on May 27, 2021, and as indicated in the Company’s press release on earlier today, resolved on a directed share issue of 2,400,000 new shares at a subscription price of SEK 135 per share, consequently raising gross proceeds of approximately SEK 324 million. The subscription price in the Issue has been determined through an accelerated book building procedure which is why the Board of Directors’ assessment is that the subscription price is in accordance with market conditions. The reasons for the deviation from the shareholders’ preferential rights are to raise capital for the development of ongoing projects in a time and cost-effective manner. Moreover, the Company will further strengthen the shareholder base with Swedish and international institutional investors and sector specialist investors through the Issue.

The Company intends to use the net proceeds from the Issue for:

ongoing clinical development;
pre-commercial development in the United States;
commercial activities for Nefecon, if approved for marketing by the FDA later this year; and
general corporate purposes.
The Issue will entail a dilution of approximately 4.6 percent of the number of shares and votes in the Company. Through the Issue, the number of outstanding shares and votes will increase by 2,400,000, from 49,941,584 to 52,341,584. The share capital will increase by SEK 96,000, from SEK 1,997,663.36 to SEK 2,093,663.36.

In connection with the Issue, the Company has agreed to a lock-up undertaking, with customary exceptions, on future share issuances for a period of 90 days. In addition, members of the Board of Directors and management of Calliditas, who owns shares or warrants, have, in connection with the Issue, agreed not to sell any shares in the Company during a lock-up period of 90 days subject to customary exceptions.

Advisers

In conjunction with the Issue, the Company has engaged Carnegie Investment Bank AB (publ) and Jefferies GmbH as Joint Global Coordinators and Joint Bookrunners, and Kempen & Co as Joint Bookrunner (together the "Banks"). Vinge act as legal adviser to the Company and Baker McKenzie act as legal adviser to the Banks.

On August 12, 2021 Aptevo Therapeutics Inc. ("Aptevo" or "the Company") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported its financial results and business highlights for the quarter ended June 30, 2021 (Press release, Aptevo Therapeutics, AUG 12, 2021, View Source [SID1234586473]).

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Business Highlights

Announced results from the Company’s Phase 1 dose escalation trial evaluating lead ADAPTIR candidate, APVO436, for the treatment of acute myeloid leukemia and myelodysplastic syndromes (AML/MDS). Results showed that APVO436 was generally well tolerated and demonstrated a manageable side effect profile. Further, APVO436 showed preliminary single agent activity and an acceptable benefit to risk profile in patients with relapsed, advanced stage AML.
Activation of the Company’s Phase 1 dose expansion trial to evaluate APVO436 in adult patients with acute myeloid leukemia (AML) in a multi-center, multi-arm trial using the active recommended Phase 2 dose of 18mcg identified in the dose escalation part of the study. The expansion trial will include five discreet cohorts of 18 patients each (N=90) who will receive APVO436 in combination and monotherapy.
Announced inclusion in the Russell Microcap Index at the conclusion of the 2021 annual reconstitution. Aptevo’s inclusion in the index became effective after US market close on Friday, June 25, 2021.
"The second quarter was an exciting time for Aptevo as we announced results from our APVO436 Phase 1 dose escalation trial in AML/MDS patients, with both encouraging safety results and observed signs of clinical activity. These results drove the design and activation of the dose expansion part of the trial. This trial is currently recruiting and we anticipate dosing the first patient soon," said Marvin White, President and CEO of Aptevo. He added, "We were also very pleased to be added to the Russell Microcap, as this is a tangible indicator of our growth in the last year, achieved by a team of professionals who are singularly focused on bringing new therapeutic solutions to patients in need."

Second Quarter 2021 Financial Results Summary

Cash Position: Aptevo had cash and cash equivalents as of June 30, 2021 totaling $61.7 million, including restricted cash of $1.3 million. The restricted cash is expected to be released over the next twelve months. Aptevo’s current cash runway is extended through Q3 2022.

Royalty Revenue: Royalty revenue was $3.1 million for the three months ended June 30, 2021, related to the royalty from Pfizer on global net sales of RUXIENCE (rituximab-pvvr).On March 30, 2021, the Company entered into and closed a royalty purchase agreement (the Royalty Purchase Agreement) with an entity managed by HealthCare Royalty Management, LLC (HCR) pursuant to which the Company sold to HCR the right to receive royalty payments made by Pfizer Inc. (Pfizer) in respect of net sales of RUXIENCE. Due to our continuing involvement under our collaboration and license Agreement with Pfizer we continue to recognize royalty revenue on net sales of RUXIENCE and record the royalty payments to HCR as a reduction of the liability related to the sale of future royalties when paid. As such payments are made to HCR, the balance of the liability related to the sale of future royalties will be effectively repaid over the life of the Royalty Purchase Agreement. RUXIENCE is a registered trademark of Pfizer.

Research and Development Expenses: Research and development expenses increased by $0.3 million for the three months ended June 30, 2021, compared to the three months ended June 30, 2020. Research and development expenses increased as we continue to invest in the APVO436 clinical trial and our preclinical candidates, including ALG.APV-527, APVO603 and APVO442.

General and Administrative Expenses: General and administrative expenses increased by $1.3 million for the three months ended June 30, 2021, compared to the three months ended June 30, 2020. This increase was primarily due to higher costs for professional services.

Other Expense, Net: Other expense, net consists primarily of costs related to debt extinguishment, accrued exit fees on debt, non-cash interest on financing agreements, and interest on debt. Other expense, net was $2.3 million for the three months ended June 30, 2021 compared to approximately zero for the three months ended June 30, 2020. The increase in other expense, net is primarily related to interest expense and accrued exit fees for the MidCap Credit Agreement, as well as non-cash interest expense for the HCR Royalty Purchase Agreement.

Discontinued Operations: Income from discontinued operations was $0.1 million for the three months ended June 30, 2021 and there was no income for the three months ended June 30, 2020. For the three months ended June, 2021, we collected a deferred payment of $0.1 million from Medexus related to first quarter 2021 IXINITY sales.

Net Income (Loss): Aptevo’s net loss for the three-month period ended June 30, 2021 was $7.9 million or $1.75 per share, as compared to a net loss of $6.8 million or $2.10 per share for the corresponding period in 2020.

Liability Related to Sale of Future Royalties: We treat the HCR Royalty Purchase Agreement as a debt financing, amortized under the effective interest rate method over the estimated life of the related expected royalty stream. The liabilities related to sale of future royalties and the debt amortization are based on our current estimates of future royalties expected to be paid over the life of the arrangement. To the extent our estimates of future royalty payments are greater or less than previous estimates or the estimated timing of such payments is materially different than previous estimates, we will adjust the effective interest rate and recognize related non-cash interest expense on a prospective basis. We are not obligated to repay the proceeds received under the Royalty Purchase Agreement with HCR.

On August 12, 2021 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune T-cell activating technology, reported that it will discuss its financial results for the quarter ended June 30, 2021 and provide a business update on its conference call today (Press release, PDS Biotechnology, AUG 12, 2021, View Source [SID1234586512]).

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Recent Business Highlights:

Presented interim Phase 2 clinical data for lead product PDS0101, in an oral presentation at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting. In the National Cancer Institute-led study, tumor reduction was observed in 83% (5 of 6) of advanced HPV16-positive cancer patients who had relapsed or failed treatment with chemotherapy and radiation but had not been treated with checkpoint inhibitor therapy. Tumor reduction was reported in 58% (7 of 12) of HPV16-positive patients who in addition had also failed checkpoint inhibitor therapy.
Completed approximately $52 Million public offering that will support next phase of company growth through advancement of PDS0102 and PDS0103 into human clinical trials.
Received $4.5 Million from the sale of Net Operating Loss tax benefits through the New Jersey Economic Development Program.
Appointed immuno-oncology experts Dr. Olivera Finn and Dr. Mark Frohlich to Scientific Advisory Board.
Expanded VERSATILE-002 study of PDS0101 and KEYTRUDA in advanced head and neck cancer to include patients who have failed prior treatment with checkpoint inhibitors.
Added to Russell Microcap Index as part of the 2021 annual reconstitution based on market-capitalization rankings and style attributes.
"The second quarter has been quite significant for PDS Biotech in providing the first demonstration of the clinical potential of the Versamune-based products in treating advanced, treatment-resistant cancers. We believe the unprecedented objective responses and tumor reduction observed in our most advanced PDS0101 phase 2 clinical trial demonstrate the potential of the Versamune platform to overcome one of the most significant limitations preventing broadly effective cancer immunotherapy. Versamune has the potential to induce high levels of potent tumor-specific killer T-cells that may attack and eliminate the cancer," commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. "Our capital raise of approximately $52M in June, further strengthens our balance sheet and provides us with the capital necessary to continue advancing our promising immuno-oncology pipeline. Renowned experts in fields of prostate and MUC1 associated cancers joined our Scientific Advisory Board to facilitate development of our pipeline products. The Company is well positioned and now has the momentum to move quickly to the next phase of growth by accelerating advancement of PDS0102 and PDS0103 into clinical trials."

Interim Study Results in NCI-Led Phase 2 Clinical Study of PDS0101 Highlight Potential of Versamune

In June, the Company reported interim Phase 2 clinical trial data from one of three ongoing PDS0101 Phase 2 trials at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting. This Phase 2 trial is studying PDS0101 (Versamune-HPV16) in combination with two investigational immune-modulating agents: Bintrafusp alfa (M7824), a bifunctional "trap" fusion protein targeting TGF-β and PD-L1, and NHS-IL12 (M9241), a tumor-targeting immunocytokine. PDS0101 is an investigational immunotherapy designed to treat cancers caused by infection with HPV16 (HPV16-positive cancers) by training and activating the immune system to produce large numbers of in vivo CD8+ (killer) T-cells to target and kill tumors that are HPV16-positive.

Analysis of the interim clinical data showed that of the initial six HPV16-positive patients who had not been treated with checkpoint inhibitors, 83% (5 of 6) of the patients demonstrated an objective response (tumor reduction >30%). One patient had achieved a complete response. The reported objective response rate with current standard of care checkpoint inhibitor treatment is 12-24%. It was also reported that 100% (6/6) of the patients were still alive (median 8 months). The historical average (median) survival or life span for this patient population is 7-11 months.

Of the twelve HPV16-positive patients who had also failed treatment with checkpoint inhibitors after failing chemotherapy and radiation treatment, tumor reduction was observed in 58% (7/12). An objective response rate of 42% (5/12) and one complete response had already been achieved at the time of reporting in June. The objective response rate reported with the standard of care in this population is 5-12%. It was also reported that 83% (10/12) were still alive (median 8 months). The historical median survival or life span for this patient population is only 3-4 months.

Second Quarter 2021 Financial Results

PDS Biotech reported a net loss of approximately $0.6 million, or ($.03) per basic share and diluted share, for the three months ended June 30, 2021 compared to a net loss of approximately $2.9 million, or ($0.19) per basic share and diluted share, for the three months ended June 30, 2020. The lower net loss reported for the three months ended June 2021 is primarily due to $4.5 million received from the sale of our NJ tax benefits pursuant to the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss program.

Research and development (R&D) expenses increased 95% to approximately $2.8 million for the three months ended June 30, 2021 from approximately $1.4 million for the three months ended June 30, 2020. A significant portion of the increase is attributable to clinical expenses related to VERSATILE-002 which is enrolling and progressing according to schedule. Preliminary data on the trial is expected as previously projected in Q4 2021 or Q1 2022.

The increase of $1.3 million in 2021 was primarily attributable to an increase of $0.2 million in personnel costs, $1.0 in clinical studies and $0.1 million in manufacturing.

General and administrative expenses increased to $2.3 million for the three months ended June 30, 2021 from $1.5 million for the three months ended June 30, 2020. The increase of $0.8 million is primarily attributable to an increase in personnel costs of $0.6 million and an increase in professional services of $0.2 million..

Total operating expenses increased 74% to approximately $5.1 million for the three months ended June 30, 2021 from approximately $2.9 million for the three months ended June 30, 2020.

PDS Biotech’s cash balance as of June 30, 2021 was approximately $74.7 million.

Conference Call and Webcast

The conference call is scheduled to begin at 8:00 am ET on Thursday, August 12, 2021. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotechnology. A live webcast of the conference call will also be available on the investor relations page of the Company’s corporate website at www.pdsbiotech.com.

After the live webcast, the event will be archived on PDS Biotech’s website for 6 months. In addition, a telephonic replay of the call will be available for 6 months. The replay can be accessed by dialing 877-660-6853 (United States) or 201-612-7415 (International) with confirmation code 13721612.

On August 12, 2021 KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, reported its financial results for the second quarter ended June 30, 2021 (Press release, KemPharm, AUG 12, 2021, View Source [SID1234586560]).

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"The second quarter of 2021 and recent weeks continued what has been a period of unprecedented growth and opportunity for KemPharm, highlighted by the U.S. commercial launch of AZSTARYS," said Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. "AZSTARYS, previously KP415, was conceived based on the vision that our LAT technology was well-suited to developing a prodrug of d-methylphenidate (d-MPH) that could address key patient and prescriber demands that were underserved by ADHD products on the market at the time. Today that vision is a reality, and as the commercial rollout of AZSTARYS by Corium continues, ADHD patients and their caregivers will have the opportunity to benefit from the unique attributes inherent only to AZSTARYS. It is a truly exciting time for KemPharm and, we believe, for the millions of patients seeking a better treatment option for their ADHD symptoms."

Dr. Mickle continued, "In addition to the commercial launch of AZSTARYS, the second quarter was highlighted by the classification of serdexmethylphenidate (SDX) as a Schedule IV controlled substance by the Drug Enforcement Administration (DEA). SDX comprises 70% of the active pharmaceutical ingredient (API) in AZSTARYS, which is classified as a Schedule II controlled substance. Importantly, the classification of SDX as a Schedule IV controlled substance and the unique properties of SDX, we believe, provide us the opportunity to develop an SDX-based product candidate or candidates that could potentially address disease indications for which no therapy currently exists. We have recently initiated a clinical trial with SDX, and in the coming months we expect to report clinical data together with an SDX development plan. Based on the results of the clinical trial, this plan may involve one or more potential product candidates that have the potential to generate substantial near-term and longer-range value for the Company."

Q2 2021 Financial Results:

For Q2 2021, KemPharm reported revenue of $12.0 million, which was comprised of a $10.0 million milestone payment earned upon the DEA scheduling of SDX, and service fee revenue of $2.0 million, as compared to Q2 2020 revenue of $6.9 million, which was derived primarily from a $5.0 million milestone payment earned upon U.S. Food and Drug Administration (FDA) acceptance of the AZSTARYS New Drug Application (NDA) and service fee revenue. The service fee revenue is being earned under consulting arrangements which contractually continue through March 2022.

KemPharm’s net income for Q2 2021 was $6.2 million, or $0.18 per basic share. Recognition of a non-cash deemed dividend of $16.9 million related to the warrant exercise inducement transaction in June 2021 led to a ($10.7) million net loss attributable to common stockholders and diluted shares, or ($0.40) per basic share attributable to common stockholders and diluted share for Q2 2021, compared to net income of $0.9 million, or $0.21 per basic and diluted share for the same period in 2020. Net income for Q2 2021 was driven primarily by operating income of $5.8 million and a non-cash gain on extinguishment of debt of $0.8 million related to the forgiveness of the PPP loan, partially offset by non-cash fair value adjustment loss of $0.4 million related to derivative and warrant liability. The net operating income of $5.8 million for Q2 2021 was a change of $3.2 million compared to net operating income of $2.6 million in the same period in 2020, which was primarily due to an increase in revenue of $5.1 million and a net increase in operating expenses of $1.8 million period over period. The net increase in operating expenses was primarily due to increases in research and development expense of $0.9 million, general and administrative expenses of $0.6 million and royalty and direct contract acquisition costs of $0.4 million.

As of June 30, 2021, total cash and cash equivalents was $132.3 million, which was an increase of $56.4 million compared to March 31, 2021.

As of June 30, 2021, total shares of common stock outstanding was 34,977,923 shares, and fully diluted common shares outstanding was 46,546,998 shares, which included 4,584,889 shares issuable upon exercise of warrants. In addition, no preferred stock is outstanding as of June 30, 2021.

Conference Call Information:

KemPharm will host a conference call and live audio webcast on Thursday, August 12, 2021, at 4:30 p.m. ET, to discuss its corporate and financial results for Q2 2021.

Telephone Access: To access the conference call telephonically, interested participants and investors are required to register via the following online form: View Source

Once registered, all individuals will be provided with participant dial-in numbers, a passcode and a registrant ID, which can then be used to access the conference call.

Participants may register at any time. It is recommended that the registration process be completed at least 15 minutes prior to the start of the call.
Webcast Access: The live audio webcast with slide presentation will be accessible via the Investor Relations section of KemPharm’s website, View Source An archive of the webcast and presentation will be available for 90 days beginning at approximately 5:30 p.m. ET, on August 12, 2021.
About AZSTARYS:

AZSTARYS is an FDA-approved, once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years or older. AZSTARYS consists of SDX, KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate release d-MPH.

The complete approved prescribing information for AZSTARYS may be downloaded in PDF format here:
View Source

On August 12, 2021 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS genome editing platform, reported financial results for the second quarter ended June 30, 2021 and provided a business update (Press release, Precision Biosciences, AUG 12, 2021, View Source [SID1234586377]).

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"In the second quarter of 2021, we continued to execute on our ARCUS-edited allogeneic CAR T programs, including our anti-CD19 studies. We continue to monitor for durability of response for our PBCAR0191 dosing protocol with enhanced lymphodepletion following the interim results presented in June 2021. We also dosed the first patient in our Phase 1 study of PBCAR19B, our next-generation anti-CD19 candidate designed to evade the immune system by avoiding both T and NK cell rejection," said Matt Kane, Chief Executive Officer at Precision BioSciences. "This quarter we also advanced our preclinical in vivo gene editing programs and look forward to sharing more about our development strategy and plans to advance select in vivo programs into the clinic at our upcoming gene editing event in September."

Recent Developments and Upcoming Milestones:

Allogeneic CAR T Portfolio:

PBCAR0191: In June 2021, Precision reported updated data for its lead anti-CD19 CAR T candidate, PBCAR0191. As of May 21, 2021, 18 subjects with Relapsed/Refractory (R/R) non-Hodgkin lymphoma (NHL) completed Day 28 evaluation and received either enhanced lymphodepletion (eLD, n=12) or standard lymphodepletion (sLD, n=6) with Dose Level 3 (3.0 × 106 cells per kg) of PBCAR0191. After a single dose of PBCAR0191 following eLD, overall response rates and complete response rates were 75% and 50%, respectively, at Day ≥ 28. Five of nine responding patients (56%) who received PBCAR0191 cells following eLD remained progression-free, including 4/9 evaluable subjects with responses lasting greater than 4 months. PBCAR0191 with eLD continues to show acceptable tolerability with no evidence of graft versus host disease (GvHD) and with a similar frequency of immune effector cell-associated neurotoxicity syndrome (ICANS) and cytokine release syndrome (CRS) compared to patients who received sLD. A subset of this data set was presented at ASCO (Free ASCO Whitepaper) 2021.

PBCAR19B: In July 2021, Precision announced that the first patient in the Phase 1 study of PBCAR19B, the Company’s anti-CD19 immune-evading stealth cell candidate for patients with R/R NHL. PBCAR19B is being administered at flat dose levels, with the first dose level (2.7 × 108 CAR T cells per patient) comparable to Dose Level 3 of PBCAR0191. The primary objective of the study is to identify the maximum tolerated dose and any dose-limiting toxicities.

PBCAR20A: Precision has completed Dose Level 3 (4.8 × 108 cells per patient given as a fixed dose) of its Phase 1/2a anti-CD20 study of PBCAR20A and has paused the study until PBCAR0191 and PBCAR19B durability is demonstrated. Precision expects to provide an interim update for PBCAR20A in 2021.

PBCAR269A: Precision continues to enroll patients in its Phase 1/2a study of PBCAR269A targeting B-cell maturation antigen (BCMA) for patients with R/R multiple myeloma. In June 2021, Precision announced that it dosed the first patient in its combination arm with PBCAR269A and nirogacestat, a gamma secretase inhibitor (GSI) being developed by SpringWorks. Emerging preclinical and clinical data suggest that a GSI may increase antitumor efficacy of BCMA-targeted autologous CAR T therapy in patients with relapsed or refractory multiple myeloma. Precision expects to provide an interim update on the monotherapy arm of the study in 2021.

PBCAR269B: In April 2021, Precision announced it started conducting IND-enabling studies for PBCAR269B, its next-generation immune-evading stealth cell candidate targeting BCMA.

In Vivo Gene Correction Portfolio:

ARCUS to Target Mitochondrial DNA: In June 2021, Precision announced a paper was published in Nature Communications and highlighted the use of ARCUS genome editing to target mutant mitochondrial DNA. Led by Carlos T. Moraes, Ph.D., Esther Lichtenstein Professor in Neurology at the University of Miami Miller School of Medicine, with Ugne Zekonyte as first author, researchers reported effective use of a mitochondrial-targeted ARCUS nuclease (mitoARCUS) to edit mutant mtDNA. This is the first time ARCUS has been used to edit outside the nuclear genome and has done so with encouraging safety and efficacy in this mouse model. These results were also discussed during the United Mitochondrial Disease Foundation’s Mitochondrial Medicine 2021 Virtual "Meet the Scientific Program Faculty" in June 2021.

Gene Editing Event: Precision will host its first in vivo focused gene editing event on Thursday, September 9, 2021. The virtual event will include presentations on the Company’s in vivo gene editing business strategy, including pipeline development plans and timelines to the clinic for certain gene editing programs such as its wholly-owned PH1 program. The virtual event is expected to last approximately two hours and will be a live video webcast available through the Company’s website. Additional details for the event will follow.

Corporate:

Executive Leadership: In May 2021, Precision announced that Alex Kelly had been appointed as Chief Financial Officer, a role in which he had served in an interim capacity since January 2021. Alex oversees Precision’s finance, corporate communications, investor relations, IT, facilities and operations functions. Shane Barton, the Company’s Vice President and Corporate Controller, had been serving as interim principal accounting officer and will now serves as principal accounting officer.

Elo Life Systems:

Corporate Structure: Precision continues to explore strategic options and expects to complete any such spinout, sale or other treatment of Elo in 2021.

Quarter Ended June 30, 2021 Financial Results

Cash and Cash Equivalents: As of June 30, 2021, Precision had approximately $173.9 million in cash and cash equivalents. The Company expects that existing cash and cash equivalents, expected operational receipts, and available credit will be sufficient to fund its operating expenses and capital expenditure requirements into 2023.

Revenues: Total revenues for the second quarter ended June 30, 2021 were $68.8 million, as compared to $1.1 million for the same period in 2020. The increase of $67.7 million in revenues during the three months ended June 30, 2021 was primarily the result of a $62.0 million increase in revenue recognized under the Servier Agreement, as the performance obligation was deemed fully satisfied upon the execution of the Program Purchase Agreement. In the second quarter, the Company also recognized $5.3 million in revenue under the Lilly Agreements, compared to no revenue for the same period in 2020, as work commenced in 2021.

Research and Development Expenses: Research and development expenses were $37.2 million for the quarter ended June 30, 2021, as compared to $25.2 million for the same period in 2020. The increase of $12.0 million in research and development expenses was primarily the result of $11.3 million in expense related to the Servier Program Purchase Agreement that was recognized in the quarter ended June 30, 2021.

General and Administrative Expenses: General and administrative expenses were $9.9 million for the quarter ended June 30, 2021, as compared to $8.7 million for the same period in 2020.

Net Income (loss): Net income was $21.7 million, or $0.38 per share (basic) and $0.36 per share (diluted), for the quarter ended June 30, 2021, as compared to a net loss of ($32.7 million), or $(0.63) per share (basic and diluted) for the same period in 2020. Weighted average common shares outstanding for the quarter ended June 30, 2021 were 57,739,622 (basic) and 59,841,638 (diluted), compared to 51,909,240 (basic and diluted) for the same period in 2020.