On August 13, 2020 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported financial results for the second quarter ended June 30, 2020 (Press release, Leap Therapeutics, AUG 13, 2020, sec.gov/Archives/edgar/data/1509745/000110465920094315/tm2027468d1_ex99-1.htm [SID1234563574]).

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Leap Second Quarter Highlights:

Completed a $51.75 million public offering of common stock and pre-funded warrants to purchase common stock
Presented updated data for DKN-01 monotherapy that showed a complete response and partial response in endometrial cancer patients with additional responses observed for the DKN-01 plus paclitaxel combination in carcinosarcoma patients
Announced Orphan Drug Designation of DKN-01 for the treatment of gastric and gastroesophageal junction cancer
"Our partnership with BeiGene for the clinical development and commercialization of DKN-01 is progressing extremely well, and we look forward to dosing the first patient this quarter in the combination study of DKN-01 plus tislelizumab, BeiGene’s anti-PD-1 antibody, for the treatment of gastric or gastroesophageal junction cancer patients," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "DKN-01 continues to show potential to treat multiple biomarker-defined cancers, as both a single agent and in combination with chemotherapy or anti-PD-1 therapies. We are excited about the promise of this program and, with the proceeds from our recent public offering, are well funded to drive development forward."

Business Update

Leap Completed $51.75 Million Public Offering of Common Stock and Pre-Funded Warrants to Purchase Common Stock – In June 2020, Leap announced the closing of an underwritten public offering yielding aggregate gross proceeds of $51.75 million, before deducting underwriting discounts and commissions and other offering expenses payable by Leap.
DKN-01 Clinical Update

DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein, a modulator of Wnt/Beta-catenin signaling. DKK1 has an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment.

Leap Presented Updated Data for DKN-01 Monotherapy and Paclitaxel Combination in Gynecologic Cancers – Leap announced updated clinical data from its ongoing Phase 2 clinical trial of DKN-01, as both a monotherapy and in combination with paclitaxel chemotherapy, in patients with advanced gynecological malignancies. Leap hosted a conference call with Rebecca Arend, M.D., Assistant Professor and Associate Scientist, Gynecologic Oncology Clinic, The University of Alabama at Birmingham School of Medicine Comprehensive Cancer Center Experimental Therapeutics Program, on April 23, 2020, to discuss the data. Key findings from the P204 study include the following:
DKN-01 Monotherapy in Endometrial Cancer: Twenty-nine endometrial cancer patients were enrolled in the DKN-01 monotherapy arm, over 75% of whom had experienced three or more prior lines of therapy. Of those patients, 26 were evaluable for response. In the 20 patients with a Wnt signaling alteration, one patient (5%) has an ongoing complete response, one patient (5%) had a partial response, eight patients (40%) had a best response of stable disease, and 10 patients (50%) had progressive disease, representing an overall response rate (ORR) of 10% and a disease control rate (DCR) of 50%. In the group of six patients without any Wnt signaling alterations, one patient (16.6%) had a best response of stable disease and five patients (83.3%) had progressive disease.
DKN-01 plus Paclitaxel in Carcinosarcoma: Fifteen patients with carcinosarcoma were enrolled in the DKN-01 plus paclitaxel arm, six of whom were evaluable for response as of the data-cutoff date. Two patients (33%) have had a partial response, one patient (17%) has had a best response of stable disease, and three patients (50%) had progressive disease, representing an ORR of 33% and a DCR of 50%. Nine patients had not reached their first tumor assessment.
Leap Announced Orphan Drug Designation of DKN-01 for the Treatment of Gastric and Gastroesophageal Junction Cancer – Leap announced that the U.S. Food and Drug Administration (FDA) granted the Company Orphan Drug Designation for DKN-01 for the treatment of gastric and gastroesophageal junction cancer. The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides to Leap certain benefits, including market exclusivity upon regulatory approval if received, exemption of FDA application fees, and tax credits for qualified clinical trials.
Selected Second Quarter 2020 Financial Results

Net loss was $6.5 million for the second quarter 2020, compared to $8.4 million for the same period in 2019. This decrease was primarily due to revenue recognized from the BeiGene agreement, a decrease in clinical development expenses and non-cash foreign currency gains associated with changes in the Australian dollar exchange rate related to certain manufacturing activities.

Research and development expenses were $5.4 million for the second quarter 2020, compared to $6.1 million for the same period in 2019. The decrease was primarily due to lower clinical trial costs due to timing of patient enrollment and lower consulting fees associated with research and development activities.

General and administrative expenses were $2.5 million for the second quarter 2020, compared to $2.3 million for the same period in 2019. The increase was primarily due to higher legal, audit and consulting fees associated with corporate and business development activities.

Cash, cash equivalents and marketable securities totaled $64.9 million at June 30, 2020. Research and development incentive receivables, current and long term, totaled approximately $0.3 million at June 30, 2020.

On August 13, 2020 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, reported financial results for the second quarter ended June 30, 2020 (Press release, Forma Therapeutics, AUG 13, 2020, View Source [SID1234563573]). The Company also highlighted recent progress and upcoming milestones for its pipeline programs.

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"This year, to date, has been very productive for Forma. We completed an upsized initial public offering, which will allow us to advance both our core assets, FT-4202, a potentially foundational, disease-modifying therapy for patients with sickle cell disease, and FT-7051, in development for mCRPC with the potential to address prostate cancer cell resistance related to molecular alterations in androgen receptors. In addition, our board of directors welcomed Dr. Wayne Frederick, who is not only a distinguished doctor and president of Howard University but also lives with sickle cell disease," said Frank Lee, president and chief executive officer of Forma Therapeutics. "We look forward to continuing Forma’s momentum by providing several clinical updates before the end of the year, including topline data from our FT-4202 multiple ascending dose study and interim data from a non-core asset, olutasidenib, Phase 2 clinical trial in patients with relapsed/refractory acute myeloid leukemia."

Key Business and Clinical Highlights

PKR Program in Sickle Cell Disease (SCD):

Received FDA Orphan Drug Designation for FT-4202 in Sickle Cell Disease. FT-4202 is being evaluated in a randomized, multi-center, placebo-controlled Phase 1 trial in SCD patients ages 12 years and older and has been granted fast track, rare pediatric and orphan drug designations. FT-4202 is a potent activator of pyruvate kinase-R (PKR) designed to improve red blood cell (RBC) metabolism, function and survival by decreasing 2,3 DPG and increasing ATP, potentially resulting in both increased hemoglobin levels and reduced vaso-occlusive crises.
Reported Favorable Single Dose Cohort Data of Patients with SCD at EHA (Free EHA Whitepaper): Results presented at the 25th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress in June 2020 demonstrated a favorable tolerability profile and biologic effects of FT-4202, with evidence of pharmacodynamic activity translating into increased oxygen affinity, a shift in the point of sickling to lower oxygen tensions, improved membrane deformability of sickle RBCs and an increased hemoglobin (on average 0.9 g/dL vs. placebo) at 24 hours post-single dose. These initial findings supported the initiation of the multiple ascending dose cohort in patients with SCD and continued planning for the global Phase 2/3 trial in SCD patients.
CPB Program in Prostate Cancer:

Presented Data Demonstrating Antitumor Activity of a Potent and Selective Inhibitor of CBP/p300 at AACR (Free AACR Whitepaper): Forma presented preclinical data on FT-6876, a predecessor molecule to clinical development candidate FT-7501, at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) in June 2020 that demonstrated antitumor activity in androgen receptor (AR)-dependent breast cancer cell lines and highlighted the possible role of CREB-binding protein/E1A binding protein p300 (CBP/p300) in proliferation and survival of AR-independent tumors. Inhibition of CBP/p300 in vitro can suppress AR and AR-v7 driven transcription of genes that drive the growth of prostate cancer cells.
FDA Cleared Investigational New Drug application for FT-7051. In April 2020, the FDA cleared Forma’s investigational new drug application for FT-7051. We expect to initiate a Phase 1 trial in mCRPC patients in the fourth quarter of 2020.
IDH1 Program in AML and Glioma:

Announced Positive IDH1 Inhibitor Data for Olutasidenib in Glioma at ASCO (Free ASCO Whitepaper): Forma announced positive preliminary Phase 1 data for olutasidenib in refractory, predominantly enhancing glioma at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), suggesting the potential for response and prolonged disease control in both non-enhancing and enhancing phenotypes of relapsed/refractory IDH1-mutated glioma patients. Olutasidenib is a selective inhibitor for cancers with IDH1 mutations and is being evaluated in a registrational Phase 2 trial for relapsed/refractory acute myeloid leukemia (R/R AML) and an exploratory Phase 1 trial for glioma and other IDH1m solid tumor indications.
Corporate:

Completed Upsized Initial Public Offering: In June 2020, Forma completed an upsized IPO of 15,964,704 shares of common stock, including the full exercise of the underwriter’s over-allotment option, resulting in gross proceeds of approximately $319.3 million before deducting underwriting discounts and commissions and other offering expenses.
Strengthened Executive Team with Appointment of David N. Cook, Ph.D., as Chief Scientific Officer
Transitioned Board of Directors Composition: Following Forma’s IPO, Dr. Steve Hall departed the board of directors and Dr. Wayne A. I. Frederick joined.
Upcoming Milestones

Updated Data to Inform Pivotal Trial in SCD: Forma plans to announce topline data from the ongoing trial of FT-4202 in SCD patients in the fourth quarter of 2020, including data from multiple ascending dose cohorts. The results of this trial will inform a global pivotal Phase 2/3 trial for people living with SCD, which is expected to initiate in the first half of 2021.
Initiation of Clinical Development in mCRPC: We continue to make progress to initiate a Phase 1 trial of FT-7051 in mCRPC patients in the fourth quarter of 2020.
Additional Data from Non-core IDH1 Program: Forma plans to announce topline data from a second interim analysis of the registrational cohort of an olutasidenib trial in relapsed/refractory AML (R/R AML) in the fourth quarter of 2020.
Possibility of COVID-19 Impact: The COVID-19 pandemic remains a factor in the successful completion of these milestones. Many clinical trials across the biopharma industry have been impacted by the COVID-19 pandemic, with clinical trial sites implementing new policies in response to COVID-19, resulting in potential delays to enrollment of clinical trials or changes in the ability to access sites participating in clinical trials.
Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $414.3 million as of June 30, 2020, as compared to $173.2 million as of December 31, 2019.
Research and Development (R&D) Expenses: R&D expenses were $20.5 million for the quarter ended June 30, 2020, compared to $28.1 million for the quarter ended June 30, 2019. The decrease was primarily due to planned reductions in spending on FT-2101, FT-4101, FT-8225, research, as well as internal R&D personnel-related costs, which were partially offset by increases in FT-4202 expenses to conduct the Phase 1 trial and preparations for our planned pivotal Phase 2/3 trial.
General and Administrative (G&A) Expenses: G&A expenses were $6.4 million for the quarter ended June 30, 2020, compared to $5.7 million for the quarter ended June 30, 2019. The increase was primarily due to increases in professional fees and stock-based compensation, partially offset with lower personnel-related costs.
Net Income/Loss: Net loss was $25.4 million for the quarter ended June 30, 2020, compared to $14.8 million for the quarter ended June 30, 2019.

On August 13, 2020 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, reported its financial results for the second quarter ended June 30, 2020 and provided a corporate update (Press release, Xenetic Biosciences, AUG 13, 2020, View Source [SID1234563572]).

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"The second quarter was marked by the achievement of important milestones for the Company. We previously announced that we would seek to utilize academic collaborators, which we believe provides many significant advantages to our overall XCART program, including access to leading CAR T experts as well as manufacturing facilities with the ability to carry out our early development activities," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "Now that we have entered into strategic collaboration agreements with Scripps Research and Pharmsynthez, we believe we are well-positioned to efficiently advance our XCART program through preclinical development and into the clinic. We will be working closely with both institutions to develop the manufacturing methods for XCART and generate key preclinical data to support a potential Phase 1 dosing study."

XCART Platform Technology Overview: Significantly differentiated, proprietary approach to personalized CAR T therapy for the treatment of multiple tumor types of B-cell Non-Hodgkin lymphomas, an area of significant unmet need, with the potential to address an initial global market opportunity of over $5 billion annually.[1] Xenetic believes XCART has the potential to transform CAR T therapy.

Program Highlights:

Collaboration with Pharmsynthez and multiple academic institutions in Russia and Belarus to optimize the overall XCART workflow, including clinical manufacturing processes, and to ultimately dose B-cell non-Hodgkin lymphoma (NHL) patients.
Research and development collaboration with Scripps Research covering design and implementation of the preclinical development program, as well as method development activities supporting process development for clinical manufacturing.
PolyXen Platform Technology: Patent-protected platform technology designed for protein or peptide therapeutics, enabling next-generation biological drugs by prolonging a drug’s circulating half-life and potentially improving other pharmacological properties.

Program Highlights:

Exclusive License Agreement with Takeda Pharmaceuticals Co. Ltd. ("Takeda") in the field of coagulation disorders. Takeda currently has one active development program underway utilizing the PolyXen platform technology.
Royalty payments doubled during the second quarter as the relevant product has now launched worldwide and continues to be rolled out by Takeda’s sublicensee.
Summary of Financial Results for Second Quarter 2020

Net loss for the six months ended June 30, 2020 was approximately $2.1 million compared to a net loss of approximately $2.7 million for the same period in 2019. As of June 30, 2020, working capital was $8.3 million compared to $9.7 million as of December 31, 2019. The decrease in working capital was primarily due to the Company’s net loss for the six months ended June 30, 2020. The Company ended the quarter with approximately $8.1 million of cash.

On August 13, 2020 Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer, reported that net revenues for its fiscal 2020 third quarter ended June 30, 2020 increased to $10.3 million, based on sharply higher U.S. prescription sales of FC2 (Press release, Veru, AUG 13, 2020, View Source [SID1234563571]).

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Third-Quarter Financial Highlights: Fiscal 2020 vs Fiscal 2019

Net revenues increased 6% to $10.3 million from $9.7 million
FC2 U.S. prescription sales climbed 23% to $5.4 million from $4.4 million
Gross profit was $6.5 million, or 63% of net revenues, compared with $6.6 million, or 68% of net revenues
Operating loss narrowed to $1.4 million from $1.8 million
Net loss was $3.0 million, or $0.05 per share, compared with $2.8 million, or $0.04 per share
Year-to-Date Financial Highlights: Fiscal 2020 vs Fiscal 2019

Net revenues rose 34% to $30.8 million from $23.1 million
FC2 U.S. prescription sales increased 95% to $18.4 million from $9.4 million
Gross profit of $21.2 million, or 69% of net revenues, significantly improved from $15.8 million, or 69% of net revenues
Balance Sheet Information

Cash and cash equivalents were $15.4 million as of June 30, 2020 versus $2.6 million as of March 31, 2020
Net accounts receivable were $4.1 million as of June 30, 2020 versus $5.8 million as of March 31, 2020
"Strong U.S. prescription sales of FC2, along with a solid contribution from PREBOOST / Roman Swipes and lower operating expenses, fueled our improved financial performance over last year’s fiscal third quarter and our substantial Year-to-Date growth in revenues and gross profit," said Mitchell Steiner, MD, Chairman, President and Chief Executive Officer of Veru Inc. "Our continued robust growth validates the strategic decision we made almost 3 years ago to utilize the growing telemedicine channel. We are pleased not only with our overall financial results, but also that our commercial sexual health business continues to generate significant funding to invest in the advancement of our clinical development programs."

Pharmaceutical Pipeline Recent Highlights:

VERU-111 for Metastatic Castration Resistant Prostate Cancer

In July the Company announced that it had received input from the U.S. Food and Drug Administration (FDA) on its pivotal Phase 3 trial design for VERU-111, an oral, first-in-class, novel alpha and beta tubulin targeting drug candidate being evaluated for the treatment of metastatic castration and novel androgen receptor targeting agent resistant prostate cancer.

"We received positive FDA input, agreement, and regulatory guidance regarding the design of the pivotal Phase 3 registration clinical trial for VERU-111," said Dr. Steiner. "We received clarity on a number of items including: the proposed indication of metastatic castration and novel androgen receptor targeting agent resistant prostate cancer, which is prior to IV chemotherapy population, being acceptable; an open label, randomized, active control study using an alternative novel androgen receptor targeting agent as the active control is reasonable; and a primary endpoint for the trial of radiographic progression-free survival. This last item is especially important because by allowing radiographic progression-free survival as an endpoint the sample size for the Phase 3 study could be potentially between 200 and 300 men. We plan to submit the final Phase 3 protocol to FDA in the fourth quarter of the current calendar year."

Dr. Steiner added: "Patient enrollment of the Phase 2 trial is nearing completion and we are already observing some significant PSA declines. We anticipate commencing the global Phase 3 pivotal clinical study in the first quarter of calendar year 2021. As this study will be conducted in the U.S. and globally, we plan to get input from the European Medicines Agency (EMA) as well."

In July the Company also announced that the clinical results from its Phase 1b/2 study of VERU-111 have been accepted for oral presentation at the prestigious European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 to be held September 19-21, 2020.

VERU-100 for Hormone Sensitive Advanced Prostate Cancer Phase 2 Clinical Trial

VERU-100, a long acting gonadotropin antagonist peptide 3-month depot formulation, GMP manufacturing is progressing and an IND expected to be submitted next quarter. The Phase 2 dose finding clinical study should start late calendar year Q4 2020 and a Phase 3 pivotal registration clinical study is expected to commence in the second half of calendar year 2021.

VERU-111 COVID-19: Phase 2 Clinical Trial

As previously announced, the Company is developing VERU-111 which has potentially both antiviral and anti-inflammatory dual action to broadly treat the cytokine storm which is associated with high COVID-19 mortality rates. The Company received FDA permission to initiate a Phase 2 clinical trial to assess the efficacy of VERU-111 in combating COVID-19 in patients at high risk for acute respiratory distress syndrome (ARDS). We recently reported the results of an in vitro study conducted by a team of researchers at the University of Tennessee Health Science Center to determine if VERU-111 can suppress toxic shock levels of these key cytokines of the cytokine storm. At a concentration that represents the blood levels of VERU-111 observed in clinically dosed patients, VERU-111 (40 nM) highly significantly reduced the production of key cytokines known to be involved with COVID-19 cytokine storm: TNFα (-31%), IL-1α (-123%), IL-1β(-97%), IL-6 (-85%), and IL-8 homologue (-96%), all p values were (p<0.001). This reduction was similar to, or greater than, depending on the specific cytokine, to that observed with dexamethasone (10nM), a steroid and a known inhibitor of cytokine production during inflammation. Suppression of these key cytokines may be an effective way to prevent clinical deterioration of patients with COVID-19 to ARDS.

The Phase 2 clinical trial is a double-blind randomized (1:1) placebo-controlled trial evaluating daily oral doses of 18 mg VERU-111 for 21 days versus placebo in 40 hospitalized COVID-19 patients who are at high risk for ARDS. The primary efficacy endpoint is the proportion of subjects that are alive without respiratory distress at Day 29. Secondary endpoints include measures of improvements on the WHO Disease Severity Scale (8-point ordinal scale), which captures COVID-19 disease symptoms and signs, including hospitalization to progression of pulmonary symptoms to mechanical ventilation, as well as improving overall survival.

Event Details
Veru Inc. will host a conference call today at 8 a.m. ET to review the Company’s performance. Interested investors may access the call by dialing 800-341-1602 from the U.S. or 412-902-6706 from outside the U.S. and asking to be joined into the Veru Inc. call. The call will also be available through a live, listen-only audio broadcast via the Internet at www.verupharma.com. A playback of the call will be archived and accessible on the same website for at least three months. A telephonic replay of the conference call will be available, beginning the same day at approximately 12 p.m. (noon) ET by dialing 877-344-7529 for U.S. callers, or 412-317-0088 from outside the U.S., passcode 10146652, for one week.

On August 13, 2020 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics targeting infectious diseases and cancers based on its proprietary arenavirus platform, reported its financial results for the second quarter ended June 30, 2020 and provides a corporate update (Press release, Hookipa Pharma, AUG 13, 2020, View Source [SID1234563570]).

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"In the second quarter, we released positive interim safety and immunogenicity results from our Phase 2 trial of HB-101 to prevent Cytomegalovirus (CMV) infections. HB-101 was observed to be well tolerated and immunogenic in patients with end-stage kidney disease. Antibody and T cell immunogenicity data confirm our Phase 1 results," commented Joern Aldag, HOOKIPA’s Chief Executive Officer. "Furthermore, our immuno-oncology trial using HB-201 monotherapy for patients with HPV16+ tumors is progressing well and has recently completed enrollment at the second dose level in the intravenous group. The HB-202 Investigational New Drug (IND) was cleared by the U.S. Food and Drug Administration (FDA), allowing the alternating use of two vectors (HB-202 + HB-201) in this trial. We expect to begin treating HPV16+ patients with this new alternating, two-vector therapy in late 2020. We plan to report further data on the HB-101 program by the end of 2020 and initial data from the HB-201 monotherapy program by late 2020/early 2021."

R&D Pipeline Update and Clinical Progress

HB-101, lead product candidate in infectious diseases
HOOKIPA’s prophylactic Cytomegalovirus (CMV) vaccine candidate, HB‑101, is in a randomized, double‑blinded Phase 2 clinical trial in patients awaiting kidney transplantation who are at risk for CMV-associated complications post-transplant. In June 2020, HOOKIPA announced positive Phase 2 interim data on the trial’s primary endpoints: safety, and B cell and T cell immunogenicity. The interim data demonstrated that HB‑101 was well tolerated, with a lower rate of adverse events in patients with end-stage kidney disease than in the Phase 1 healthy volunteer trial. Patients who received the protocol recommended three doses of HB‑101 showed comparable immunogenicity levels to those measured in the Phase 1 healthy volunteer trial. HOOKIPA continues to accrue patients, and plans to report preliminary efficacy and updated safety and immunogenicity data by the end of 2020.

HB-201 and HB-202, lead programs in immuno-oncology treating Human Papillomavirus-positive cancers
HOOKIPA’s lead oncology product candidates, HB‑201 and HB‑202, are in development for the treatment of Human Papillomavirus 16‑positive (HPV16+) cancers. In December 2019, HOOKIPA initiated the Phase 1/2 clinical trial for HB-201. The open label, dose escalating Phase 1/2 clinical trial is evaluating HB-201 in HPV16+ cancers alone and in combination with an approved checkpoint inhibitor. HOOKIPA plans to enroll 100 patients in total with 20 patients in each dose escalation and expansion group, respectively. Enrollment of patients at the intravenously administered first and second dose levels has been completed. HOOKIPA expects to report preliminary safety and efficacy data in late 2020 or early 2021.

In June 2020, HOOKIPA announced that the FDA cleared its IND Application for HB-202. With the IND clearance, HOOKIPA will be able to examine not only the safety and efficacy of HB‑201 alone but also HB-201 in combination with HB-202 as an alternating, two-vector therapy. The planned clinical trial combining HB-202 with HB-201, also in patients with HPV16+ cancers, is an open label, dose escalation Phase 1/2 trial with the primary endpoint to evaluate safety and tolerability. That trial is expected to commence later in 2020.

In August 2020, the United States Patent and Trademark Office (USPTO) and the European Patent Office issued patents to the University of Geneva, licensed exclusively to HOOKIPA, that cover HOOKIPA´s proprietary replicating arenavirus technology (TheraT), including HB-201 and HB-202. The USPTO also granted a patent specifically related to HB-201 and HB-202 product candidates.

Strategic Collaborations

Gilead Sciences Collaboration for HIV and HBV Therapeutic Vaccines
Since the start of the collaboration in 2018, HOOKIPA received $21.0 million in upfront and milestone payments from Gilead for the delivery of research vectors and for advancing the programs towards clinical trials, including a milestone payment of $4.0 million, which the Company received in early 2020. Based on preclinical data generated to date, Gilead committed to advancing the HBV and HIV vectors toward development. To enable the development activities and expanded research programs, Gilead agreed to reserve manufacturing capacity and increase reimbursement planned for the Company’s expanded resources allocated to the Gilead collaboration. The HOOKIPA team has continued to meet all milestones agreed with Gilead on time despite the pandemic.

COVID-19
HOOKIPA continues to monitor the COVID-19 situation closely and to adapt to the COVID-19 measures and recommendations issued by the US and Austrian governments. For disclosures of risks and uncertainties resulting from the COVID-19 disease outbreak, including the impact on the enrollment of patients and timing of clinical results, see HOOKIPA’s quarterly report on Form 10-Q for the quarter ended June 30, 2020.

Second Quarter 2020 Financial Results

Cash Position:
HOOKIPA’s cash, cash equivalents and restricted cash as of June 30, 2020 was $93.3 million compared to $113.6 million as of December 31, 2019. The decrease was primarily attributable to cash used in operating activities.

Revenue was $6.7 million for the three months ended June 30, 2020 compared to $4.1 million for the three months ended June 30, 2019. The increase was primarily due to higher cost reimbursements received under the collaboration agreement with Gilead and the partial recognition of a milestone payment we received from Gilead in February 2020.

Research and Development Expenses:
HOOKIPA’s research and development expenses were $11.6 million for the three months ended June 30, 2020 compared to $13.9 million for the three months ended June 30, 2019.

The primary drivers of the decrease compared to 2019 were a decrease in manufacturing and quality control expenses of $2.0 million along with a general decrease in other direct R&D expenses of $1.1 million.

General and Administrative Expenses:
General and administrative expenses amounted to $4.3 million for the three months ended June 30, 2020 compared to $3.8 million for the three months ended June 30, 2019. The increase was primarily due to an increase in personnel-related expenses and in costs associated with ongoing business activities and operating as a public company, which was partially offset by a decrease in professional and consulting fees which resulted from the prior-year effect related to the closing of the Company’s initial public offering in April 2019.

Net Loss:
HOOKIPA’s net loss was $7.1 million for the three months ended June 30, 2020 compared to a net loss of $12.1 million for the three months ended June 30, 2019.