Coming off its record-breaking initial public offering (IPO) in December, where it raised $604.3 million, Moderna released its fourth-quarter financials, outlining an ambitious company buzzing with activity.
Coming off its record-breaking initial public offering (IPO) in December, where it raised $604.3 million, Moderna released its fourth-quarter financials, outlining an ambitious company buzzing with activity.
Financially, the company notes its cash, cash equivalents and investments as of Dec. 31, 2018 were $1.7 billion. Net cash used in operating activities for the year was $330.9 million, with another $105.8 million used to buy property and equipment. Much of that was related to the Norwood manufacturing facility, where it spent $94.8 million in 2018. The plant opened in July 2018.
The company brought in $35.4 million in revenue for the fourth quarter and $135.1 million for the full year. Both were down from the same periods the previous year, from $91.9 million for fourth-quarter 2017 and $205.8 million for 2017. The drop was primarily related to the termination of a strategic alliance with Alexion in October 2017 and a decrease in grant revenue from the Biomedical Advanced Research and Development Authority (BARDA) contract.
Moderna indicates it expects to have cash, cash equivalents and investments at the end of this year ranging from $1.15 billion to $1.20 billion.
But what is most striking about the company’s fourth-quarter and annual report is the depth and breadth of its programs. It currently has 20 mRNA development candidates in its portfolio, with 11 in the clinic. More than 1,000 patients have enrolled in various clinical trials.
The newest updates are the preparation of an investigational new drug (IND) submission to the U.S. Food and Drug Administration (FDA) for a follow-on Zika vaccine program (mRNA-1893), while it is no longer developing its first Zika vaccine candidate, mRNA-1325. It has submitted a randomized Phase II protocol to the FDA for its personalized cancer vaccine, mRNA-4157 in patients with resected melanoma, and its IND has been opened for a Phase I trial of mRNA encoding IL12 (MEDI1191) injected intratumorally in solid tumors.
Under its rare diseases area, the FDA granted Fast Track status to its methylmalonic acidemia (MMA) program, mRNA-3701, and opened an IND for Phase I/II trial of pediatric patients.
“Execution by our team has enabled us to make important pipeline progress so far this year,” stated Stephane Bancel, Moderna’s chief executive officer. “We now have two additional programs ready for Phase II clinical development, newly opened INDs for our first rare disease program and a fifth immuno-oncology program, dosed the first cohort in a study of our systematically delivered mRNA that encodes for a secreted monoclonal antibody, and recently reported positive interim Phase I data for a novel combination vaccine designed to protect against viruses that can cause severe respiratory diseases in children.”
The company expects to announce data for several programs over the next 12 to 24 months.
In the area of prophylactic vaccines, the company announced positive data from a planned interim safety and immunogenicity analysis of its hMPV-PIV3 (mRNA-1653) Phase I trial in healthy adults. The compound is designed as a vaccine against human Metapneumovirus (hMPV) and Parainfluenza Virus Type 3 (PIV3). As mentioned above, BARDA is still supporting a Zika vaccine, but the company is not continuing work on its first Zika candidate.
For cancer vaccines, Moderna and Merck submitted a new protocol to the FDA for its mRNA-4157 to start a randomized Phase II trial to evaluate whether postoperative adjuvant therapy with mRNA-4157, in combination with Merck’s Keytruda, improved recurrence-free survival compared to Keytruda alone.
In the area of intratumoral immuno-oncology, its mRNA-2752 has cleared dosing of the first cohort of patients in the Phase I trial and dosing of a second cohort has begun. mRNA-2752 is also called Triplet. It is an intratumoral injection made up of three mRNAs for the treatment of advanced or metastatic solid tumors or lymphoma. It is evaluating the safety and tolerability of the compound alone and in combination with either AstraZeneca’s durvalumab or tremelimumab.
Also, in this area, the company has an IND opened for a Phase I trial of mRNA encoding IL12 injected intratumorally in advanced or metastatic solid tumors, again, alone or in combination with an AstraZeneca’s checkpoint inhibitor.
The company also has programs ongoing in systemic secreted therapeutics with an antibody against the Chikungunya virus (mRNA-1944) and methylmalonic acidemia (mRNA-3704).
Bancel stated, “Our strong cash position enables us to focus on advancing investigational medicines in our pipeline, pursue new candidates within our existing modalities and continue to invest in our mRNA platform to discover new modalities and treatments for patients across a broader range of disease areas.”
